| PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
|---|---|---|---|---|
|
P060001
S050 |
30-Day Notice | Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System |
MEDTRONIC VASCULAR INC | 07/25/2025 |
|
P110023
S060 |
30-Day Notice | EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent With Entrust™ Delivery Syste |
MEDTRONIC VASCULAR INC | 07/25/2025 |
|
P140003
S128 |
30-Day Notice | Impella 2.5, Impella CP, Impella CP With SmartAssist, Impella 5.0, Impella 5.5 With SmartAssist, And Impella LD |
ABIOMED, INC. | 07/25/2025 |
|
P170011
S059 |
30-Day Notice | Impella RP, Impella RP With SmartAssist, And Impella RP Flex With SmartAssist |
Abiomed, Inc. | 07/25/2025 |
|
P190022
S003 |
Normal 180 Day Track | 4Kscore Test | OPKO Health, Inc. | 07/25/2025 |
|
P220003
S024 |
30-Day Notice | PASCAL Precision Transcatheter Valve Repair System |
Edwards LifeSciences LLC | 07/25/2025 |
|
P230036
S012 |
30-Day Notice | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System |
Abbott Medical | 07/25/2025 |
|
P840064
S090 |
30-Day Notice | VISCOAT™ Ophthalmic Viscosurgical Device, DISCOVISC™ Ophthalmic Viscosurgical Device |
ALCON LABORATORIES | 07/25/2025 |
|
P850064
S055 |
Real-Time Process | LifePulse High Frequency Ventilator (HFV) |
BUNNELL, INC. | 07/25/2025 |
|
P890047
S068 |
30-Day Notice | PROVISC™ Ophthalmic Viscosurgical Device |
Alcon Research, Ltd. | 07/25/2025 |
|
BP170154
S031 |
Real Time Process | ID CORE XT | Progenika Biopharma, S.A. |
07/25/2025 |
|
P070004
S047 |
30-Day Notice | Sientra Silicone Gel Breast Implants | Tiger Aesthetics Medical, LLC |
07/24/2025 |
|
P130017
S064 |
30-Day Notice | Cologuard® Test | Exact Sciences Corporation |
07/24/2025 |
|
P160015
S024 |
30-Day Notice | AED Plus And Fully Automatic AED Plus |
ZOLL MEDICAL CORPORATION | 07/24/2025 |
|
P230043
S002 |
30-Day Notice | Cologuard Plus™ | Exact Sciences Corporation |
07/24/2025 |
| P250002 | Original | Quest Diagnostics AAVrh74 Antibody ELISA CDx |
QUEST DIAGNOSTICS NICHOLS INSTITUTE |
07/24/2025 |
|
P970051
S234 |
30-Day Notice | Nucleus® 24 Cochlear Implant System | Cochlear Americas | 07/24/2025 |
|
P040003
S022 |
Normal 180 Day Track No User Fee |
Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation Of Uterine Fibroids |
INSIGHTEC, LTD | 07/23/2025 |
|
P040044
S110 |
30-Day Notice | MynxGrip Vascular Closure Device (5F, 6F/7F); Mynx Control Vascular Closure Device (5F, 6F/7F); Mynx Control Venous Vasc |
Cordis US Corporation | 07/23/2025 |
|
P060027
S107 |
Normal 180 Day Track | Platinium CRT-D 1711; Platinium CRT-D 1741; Platinium 4LV CRT-D 1744; ENERGYA CRT-D 3711; ENERGYA CRT-D 3741; ENERGYA 4L |
MicroPort CRM USA Inc. | 07/23/2025 |
|
P080011
S180 |
Normal 180 Day Track No User Fee |
Up&up Monthly Performance, Up&up Monthly Performance XR, Up&up Monthly Performance For Astigmatism, Up&up Monthly Perfor |
CooperVision, Inc. | 07/23/2025 |
|
P100009
S077 |
30-Day Notice | MitraClip G5 Delivery System | Abbott Medical | 07/23/2025 |
|
P130010
S004 |
Normal 180 Day Track | VEGA R45; VEGA R52; VEGA R58; VEGA R45 RE-INTERVENTION KIT; VEGA R58 RE-INTERVENTION KIT; VEGA R45 RE-INTERVENTION KIT |
MicroPort CRM USA Inc. | 07/23/2025 |
|
P150004
S087 |
30-Day Notice | Proclaim DRG IPG | Abbott Medical | 07/23/2025 |
|
P230009
S007 |
30-Day Notice | Shield | Guardant Health, Inc. | 07/23/2025 |
|
P230013
S017 |
30-Day Notice | Edwards EVOQUE Tricuspid Delivery System |
Edwards Lifesciences LLC | 07/23/2025 |
|
P240006
S009 |
30-Day Notice | VARIPULSE™ Platform | Biosense Webster, Inc | 07/23/2025 |
|
P240013
S014 |
30-Day Notice | HexaFlow™ Irrigation Pumo AFR-00004, HexaGen TM RF Generator AFR-00005, HexaPulse TM PF Generator AFR-00008 |
Medtronic Inc. | 07/23/2025 |
|
P890057
S029 |
Real-Time Process | MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR |
ZOLL Medical Corporation | 07/23/2025 |
|
P950029
S134 |
Normal 180 Day Track | Reply SR; Reply DR; ALIZEA SR 1300; ALIZEA DR 1600; CELEA SR 1100; CELEA DR 1400 |
MicroPort CRM USA Inc. | 07/23/2025 |
|
P980049
S147 |
Normal 180 Day Track | Platinium VR 1210, Platinium VR 1240, ENERGYA VR 3110, TALENTIA VR 3210, ENERGYA VR 3140, TALENTIA VR 3240, Platinium DR |
MicroPort CRM USA Inc. | 07/23/2025 |
|
P980052
S016 |
Special (Immediate Track) |
TMJ Concepts Patient Fitted Temporomandibular Joint (TMJ) Reconstruction Prosthesis System |
TMJ CONCEPTS | 07/23/2025 |
|
P060022
S036 |
30-Day Notice | Akreos Posterior Chamber Intraocular Lens (IOL) |
Bausch & Lomb, Inc. | 07/22/2025 |
|
P080010
S028 |
30-Day Notice | TECNIS 3-Piece Multifocal, Model ZMA00 |
Johnson & Johnson Surgical Vision, Inc. |
07/22/2025 |
|
P110028
S024 |
30-Day Notice | Absolute Pro Vascular Self-Expanding Stent System |
ABBOTT VASCULAR INC. | 07/22/2025 |
|
P200037
S017 |
30-Day Notice | ASSURE Wearable Cardioverter Defibrillator (WCD) System |
Kestra Medical Technologies, Inc. |
07/22/2025 |
|
P200045
S016 |
Real-Time Process | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | 07/22/2025 |
|
P240013
S012 |
30-Day Notice | Sphere-9 Catheter And Affera Ablation System (HexaFlow™ Irrigation Pump; HexaGen™ RF Generator; HexaPulse™ PF Generator) |
Medtronic Inc. | 07/22/2025 |
|
P840001
S601 |
30-Day Notice | Master Restore™, Itrel™, Synergy Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify™, |
MEDTRONIC NEUROMODULATION |
07/22/2025 |
|
P960009
S513 |
30-Day Notice | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 07/22/2025 |
|
P980040
S175 |
30-Day Notice | TECNIS Odyssey Toric II IOL With TECNIS SIMPLICITY Delivery System, Model DRT |
Johnson & Johnson Surgical Vision, Inc. |
07/22/2025 |
|
P980044
S063 |
30-Day Notice | SUPARTZ FX; VISCO-3 | SEIKAGAKU CORP. | 07/22/2025 |
|
P990080
S063 |
30-Day Notice | TECNIS 3-Piece Acrylic Monofocal, Model ZA9003 |
Johnson & Johnson Surgical Vision, Inc. |
07/22/2025 |
|
P110015
S011 |
Normal 180 Day Track No User Fee |
13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT |
ADVANCED BREATH DIAGNOSTICS |
07/21/2025 |
|
P130008
S127 |
30-Day Notice | MODEL 3150 IMPLANTABLE PULSE GENERATOR (IPG) |
INSPIRE MEDICAL SYSTEMS | 07/21/2025 |
|
P130017
S063 |
Real-Time Process | Cologuard® | Exact Sciences Corporation |
07/18/2025 |
|
P160035
S051 |
Real-Time Process | EXCOR Pediatric Ventricular Assist Device |
Berlin Heart Inc. | 07/18/2025 |
|
P190018
S042 |
30-Day Notice | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens, |
Alcon Laboratories, LLC | 07/18/2025 |
|
P200035
S027 |
30-Day Notice | OrganOx Metra® System | OrganOx Limited | 07/18/2025 |
|
P230043
S001 |
Real-Time Process | Cologuard Plus™ | Exact Sciences Corporation |
07/18/2025 |
|
P240004
S001 |
Normal 180 Day Track No User Fee |
EndoForce™ Connector For Endovascular Venous Anastomosis |
Phraxis, Inc. | 07/18/2025 |
|
P830055
S341 |
135 Review Track For 30-Day Notice |
LCS(R) TOTAL KNEE SYSTEM | DEPUY, INC. | 07/18/2025 |
|
P990004
S075 |
30-Day Notice | SURGIFLO® Hemostatic Matrix; SURGIFLO® Hemostatic Matrix Kit With Thrombin |
Ferrosan Meidcal Devices A/S |
07/18/2025 |
|
P060001
S049 |
Special (Immediate Track) |
Protégé™ RX Carotid Stent System | MEDTRONIC VASCULAR INC | 07/17/2025 |
|
P060040
S120 |
30-Day Notice | HeartMate II Left Ventricular Assist System |
Abbott Medical | 07/17/2025 |
|
P080025
S322 |
30-Day Notice | InterStim® Therapy System, Verify® Evaluation System |
MEDTRONIC NEUROMODULATION |
07/17/2025 |
|
P080025
S324 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
MEDTRONIC NEUROMODULATION |
07/17/2025 |
|
P160054
S109 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 07/17/2025 |
|
P840001
S598 |
30-Day Notice | Master Restore, Itrel®, Synergy Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify®, A |
MEDTRONIC NEUROMODULATION |
07/17/2025 |
|
P840001
S599 |
30-Day Notice | Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces-Quad™, Spe |
MEDTRONIC NEUROMODULATION |
07/17/2025 |
|
P860004
S445 |
30-Day Notice | SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
MEDTRONIC Inc. | 07/17/2025 |
|
P860004
S446 |
30-Day Notice | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters |
MEDTRONIC Inc. | 07/17/2025 |
|
P960009
S510 |
30-Day Notice | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 07/17/2025 |
|
P960009
S511 |
30-Day Notice | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 07/17/2025 |
|
P970004
S427 |
30-Day Notice | InterStim® Therapy System, Verify® Evaluation System |
MEDTRONIC NEUROMODULATION |
07/17/2025 |
|
P970004
S428 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
MEDTRONIC NEUROMODULATION |
07/17/2025 |
|
P010030
S194 |
30-Day Notice | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST |
ZOLL MANUFACTURING CORPORATION |
07/16/2025 |
|
P010030
S195 |
30-Day Notice | LifeVest® Wearable Defibrillator | ZOLL MANUFACTURING CORPORATION |
07/16/2025 |
|
P040043
S143 |
30-Day Notice | GORE® TAG® Conformable Thoracic Endoprosthesis |
W. L. GORE & ASSOCIATES, INC. |
07/16/2025 |
|
P080025
S323 |
30-Day Notice | InterStim™ Therapy System, Verify™ Evaluation System |
MEDTRONIC NEUROMODULATION |
07/16/2025 |
|
P130013
S074 |
Panel Track | WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device With Deli |
Boston Scientific Corp. | 07/16/2025 |
|
P140030
S019 |
30-Day Notice | Astron | BIOTRONIK, INC. | 07/16/2025 |
|
P200036
S008 |
Normal 180 Day Track No User Fee |
Ecoin Peripheral Neurostimulator | Valencia Technologies Corporation |
07/16/2025 |
|
P840001
S600 |
30-Day Notice | Restore; Itrel; Synergy Intellis; Vanta And Inceptiv Spinal Cord Stimulation Systems And Pisces; Specify; And Vectris Sp |
MEDTRONIC NEUROMODULATION |
07/16/2025 |
|
P850089
S172 |
30-Day Notice | CapSure SP Z Lead 5033; Vitatron Impulse II Lead IHP09, IHP09B, IHP09JB |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
07/16/2025 |
|
P890003
S480 |
30-Day Notice | CapSure VDD-2 Lead 5038, 5038L, 5038S; Vitatron Brilliant S+ VDD Lead IMW14Q, IMW15Q, IMW16Q; Vitatron Brilliant S+VDD L |
Medtronic, Inc. | 07/16/2025 |
|
P920015
S301 |
30-Day Notice | Print Quattro Lead 6935M; Sprint Quattro Lead 6947M; Sprint Quattro Lead 6947; Sprint Quattro Lead 6935 |
MEDTRONIC Inc. | 07/16/2025 |
|
P930036
S025 |
30-Day Notice | ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
07/16/2025 |
|
P930039
S273 |
30-Day Notice | CapSureFix Novus Lead 5076; Vitatron Crystalline ActFix Lead ICF09B |
Medtronic, Inc. | 07/16/2025 |
|
P950021
S030 |
30-Day Notice | ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) |
SIEMENS HEALTHCARE DIAGNOSTICS |
07/16/2025 |
|
P950024
S115 |
30-Day Notice | CapSure Epicardial Pacing Lead 4965; CapSure Epicardial Pacing Lead 4968 |
MEDTRONIC Inc. | 07/16/2025 |
|
P960009
S512 |
30-Day Notice | Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
MEDTRONIC Inc. | 07/16/2025 |
|
P970004
S429 |
30-Day Notice | InterStim Therapy System, Verify Evaluation System |
MEDTRONIC NEUROMODULATION |
07/16/2025 |
|
P990055
S029 |
30-Day Notice | ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) |
SIEMENS HEALTHCARE DIAGNOSTICS |
07/16/2025 |
|
P010031
S896 |
30-Day Notice | Cobalt MRI, CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
07/15/2025 |
|
P140010
S096 |
30-Day Notice | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C |
MEDTRONIC Inc. | 07/15/2025 |
|
P180036
S038 |
Normal 180 Day Track No User Fee |
OPTIMIZER Smart System | Impulse Dynamics (USA), Inc. |
07/15/2025 |
|
P190008
S043 |
30-Day Notice | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Medtronic Vascular Inc. | 07/15/2025 |
|
P890003
S476 |
Normal 180 Day Track | SmartSync™ Pacing System Analyzer | Medtronic, Inc. | 07/15/2025 |
|
P960009
S506 |
Real-Time Process | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 07/15/2025 |
|
P980016
S930 |
30-Day Notice | Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DVPA2D1); Cobalt XT MRI ICD (DDPA2D4, D |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
07/15/2025 |
|
BP170154
S033 |
30-Day Notice | ID CORE XT | Progenika Biopharma, S.A. |
07/15/2025 |
|
N970012
S209 |
30-Day Notice | AMS 700 Inflatable Penile Prosthesis (IPP) |
Boston Scientific Corp. | 07/14/2025 |
|
P000053
S140 |
30-Day Notice | AMS 800 Artificial Urinary Sphincter (AUS) |
Boston Scientific Corp. | 07/14/2025 |
|
P050047
S104 |
30-Day Notice | Juvéderm Ultra, Juvéderm Ultra XC, And Juvéderm Ultra Plus XC (hereafter Referred To As Ultra, Ultra XC And Ultra Plus X |
Allergan | 07/14/2025 |
|
P050052
S171 |
30-Day Notice | RADIESSE (+) Lidocaine | MERZ NORTH AMERICA, INC | 07/14/2025 |
|
P080011
S190 |
30-Day Notice | Biofinity XR Toric (comfilcon A) | CooperVision, Inc. | 07/14/2025 |
|
P110033
S100 |
30-Day Notice | Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC And SKINVIVE By Juvéderm (hereafter Ref |
Allergan | 07/14/2025 |
|
P160055
S051 |
30-Day Notice | RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD) |
RxSight, Inc. | 07/14/2025 |
|
N970003
S300 |
Real-Time Process | ALTRUA™ 2 (Models S701, S702, S722); ESSENTIO™ (Models L100, L101, L121); PROPONENT™ (Models L200, L201, L221); ACCOLADE |
Boston Scientific Corp. | 07/11/2025 |
|
P000008
S051 |
30-Day Notice | ReShape Lap-Band System | ReShape Lifesciences, Inc. |
07/11/2025 |
|
P030005
S246 |
Real-Time Process | VALITUDE™ (Model U125); VALITUDE™ X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST™ X4 (Model U228) |
GUIDANT CORP. | 07/11/2025 |
|
P100013
S031 |
30-Day Notice | EXOSEAL Vascular Closure Device | Cordis US Corporation | 07/11/2025 |
|
P140008
S027 |
Real-Time Process | Orbera® Intragastric Balloon (IGB) System |
Boston Scientific Corporation |
07/11/2025 |
|
P150012
S168 |
Real-Time Process | ESSENTIO™ MRI (Models L110, L111, L131); PROPONENT™ MRI (Models L210, L211, L231); ACCOLADE™ MRI (Models L310, L311, L33 |
BOSTONSCIENTIFIC | 07/11/2025 |
|
P150021
S060 |
30-Day Notice | FreeStyle Libre Pro Flash Glucose Monitoring System |
Abbott Diabetes Care Inc. |
07/11/2025 |
|
P160015
S021 |
Real-Time Process | AED Plus And Fully Automatic AED Plus |
ZOLL MEDICAL CORPORATION | 07/11/2025 |
|
P160022
S043 |
Real-Time Process | X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ |
ZOLL MEDICAL CORPORATION | 07/11/2025 |
|
P160030
S057 |
30-Day Notice | FreeStyle Libre 14-Day Flash Glucose Monitoring System |
ABBOTT DIABETES CARE INC. |
07/11/2025 |
|
P160054
S108 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System (LVAS) |
Abbott Medical | 07/11/2025 |
|
P180050
S015 |
Real-Time Process | BAROSTIM NEO® System | CVRx, INC. | 07/11/2025 |
|
P220003
S023 |
30-Day Notice | PASCAL Precision Transcatheter Valve Repair System |
Edwards LifeSciences LLC | 07/11/2025 |
|
P240037
S001 |
Normal 180 Day Track No User Fee |
VENTANA MET (SP44) RxDx Assay | Ventana Medical Systems Inc (Roche Tissue Diagnostics) |
07/11/2025 |
| P240020 | Original | TOUCH® CMC 1 Prosthesis | Keri Medical SA | 07/10/2025 |
|
P100030
S021 |
30-Day Notice | Preveleak Surgical Sealant | Baxter Healthcare Corporation |
07/10/2025 |
|
P140010
S094 |
30-Day Notice | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C |
MEDTRONIC Inc. | 07/10/2025 |
|
P140030
S018 |
30-Day Notice | Astron | BIOTRONIK, INC. | 07/10/2025 |
|
P160003
S025 |
30-Day Notice | PRO-Kinetic Energy Coronary Stent System |
BIOTRONIK, INC. | 07/10/2025 |
|
P160025
S020 |
30-Day Notice | Astron Pulsar; Pulsar-18; Pulsar-18 T3 |
BIOTRONIK, INC. | 07/10/2025 |
|
P170030
S057 |
30-Day Notice | Orsiro Mission Sirolimus Eluting Coronary Stent System |
Biotronik, Inc | 07/10/2025 |
|
P190002
S043 |
30-Day Notice | Saluda Medical Evoke SCS System | SALUDA MEDICAL PTY LTD | 07/10/2025 |
|
P190008
S041 |
30-Day Notice | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Medtronic Vascular Inc. | 07/10/2025 |
|
P240004
S002 |
30-Day Notice | EndoForce™ Connector For Endovascular Venous Anastomosis |
Phraxis, Inc. | 07/10/2025 |
|
P010031
S892 |
Real-Time Process | Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4, Brava CRT-D DTBC1D1; Bra |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
07/09/2025 |
|
P010031
S895 |
30-Day Notice | Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
07/09/2025 |
|
P060022
S035 |
30-Day Notice | Akreos Posterior Chamber Intraocular Lens (IOL) |
Bausch & Lomb, Inc. | 07/09/2025 |
|
P100047
S227 |
Normal 180 Day Track | HeartWare HVAD System | Medtronic | 07/09/2025 |
|
P140010
S093 |
30-Day Notice | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
MEDTRONIC Inc. | 07/09/2025 |
|
P140010
S095 |
30-Day Notice | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter And IN.PACT 018 Paclitax |
MEDTRONIC Inc. | 07/09/2025 |
|
P150033
S211 |
30-Day Notice | Micra AV TPS MC1lAVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 |
MEDTRONIC Inc. | 07/09/2025 |
|
P190008
S040 |
30-Day Notice | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Medtronic Vascular Inc. | 07/09/2025 |
|
P190008
S042 |
30-Day Notice | IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter |
Medtronic Vascular Inc. | 07/09/2025 |
|
P220012
S053 |
30-Day Notice | Epsila EV Extravascular Lead EV2401 | Medtronic, Inc. | 07/09/2025 |
|
P220025
S006 |
30-Day Notice | LimFlow System | LimFlow, Inc. | 07/09/2025 |
|
P230044
S001 |
Real-Time Process | Alfapump System | Sequana Medical NV | 07/09/2025 |
|
P920015
S300 |
30-Day Notice | Sprint Quattro Lead 6935M, Sprint Quattro Lead 6946M, Sprint Quattro Lead 6947, Sprint Quattro Lead 6947M, Sprint Quattr |
MEDTRONIC Inc. | 07/09/2025 |
|
P980016
S926 |
Real-Time Process | Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
07/09/2025 |
|
P980016
S929 |
30-Day Notice | Cobalt MRI ICD, Cobalt XT MRI ICD | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
07/09/2025 |
|
P990004
S073 |
Normal 180 Day Track | SURGIFLO™ Hemostatic Matrix Kit With Thrombin |
Ferrosan Meidcal Devices A/S |
07/09/2025 |
|
P140031
S191 |
30-Day Notice | Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) |
EDWARDS LIFESCIENCES, LLC. |
07/08/2025 |
|
P200015
S067 |
30-Day Notice | Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29) |
Edwards Lifesciences, LLC |
07/08/2025 |
|
P120003
S006 |
Normal 180 Day Track | Icast Covered Stent System | ATRIUM MEDICAL CORP. | 07/07/2025 |
|
P240013
S011 |
30-Day Notice | Sphere-9 Catheter And Affera Ablation System |
Medtronic Inc. | 07/07/2025 |
|
P150038
S037 |
Panel Track | Exablate Model 4000 Type-1 System | InSightec | 07/03/2025 |
|
P230030
S007 |
Panel Track | FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C |
FARAPULSE, Inc. | 07/03/2025 |
|
P000015
S053 |
Normal 180 Day Track | Nucleus® 24 Auditory Brainstem Implant System |
Cochlear Americas | 07/03/2025 |
|
P030053
S077 |
Normal 180 Day Track No User Fee |
MENTOR MemoryGel Enhance Breast Implants |
MENTOR CORP. | 07/03/2025 |
|
P100022
S044 |
30-Day Notice | Zilver® PTX® Peripheral Drug-Eluting Stent |
Cook Ireland, Ltd. | 07/03/2025 |
|
P130016
S056 |
Normal 180 Day Track | Nucleus® Hybrid™ L24 Cochlear Implant System |
Cochlear Americas | 07/03/2025 |
|
P160032
S013 |
Special (Immediate Track) |
Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E |
DEFIBTECH, LLC | 07/03/2025 |
|
P170008
S058 |
30-Day Notice | EluNIR™ Ridaforolimus Eluting Coronary Stent System |
Medinol, Ltd. | 07/03/2025 |
|
P230001
S008 |
Normal 180 Day Track No User Fee |
ColoSense® | Geneoscopy, Inc. | 07/03/2025 |
|
P840001
S597 |
30-Day Notice | Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify™ |
MEDTRONIC NEUROMODULATION |
07/03/2025 |
|
P840024
S096 |
Normal 180 Day Track | Nucleus® 22 Cochlear Implant System | Cochlear Americas | 07/03/2025 |
|
P890027
S064 |
Normal 180 Day Track | Nucleus® 22 Cochlear Implant System | Cochlear Americas | 07/03/2025 |
|
P960009
S509 |
30-Day Notice | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 07/03/2025 |
|
P970051
S225 |
Normal 180 Day Track | Nucleus® 24 Cochlear Implant System | Cochlear Americas | 07/03/2025 |
|
P010015
S566 |
30-Day Notice | MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM |
MEDTRONIC Inc. | 07/02/2025 |
|
P010031
S894 |
30-Day Notice | CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
07/02/2025 |
|
P010032
S239 |
30-Day Notice | Proclaim SCS IPG | Abbott Medical | 07/02/2025 |
|
P110001
S021 |
30-Day Notice | RX HERCULINK ELITE RENAL STENT SYSTEM |
ABBOTT VASCULAR | 07/02/2025 |
|
P140009
S120 |
30-Day Notice | Infinity DBS IPG | Abbott Medical | 07/02/2025 |
|
P150004
S086 |
30-Day Notice | Proclaim DRG IPG | Abbott Medical | 07/02/2025 |
|
P150033
S210 |
30-Day Notice | MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM |
MEDTRONIC Inc. | 07/02/2025 |
|
P150035
S024 |
Real-Time Process | Aveir VR And DR Delivery Catheters | Abbott Medical | 07/02/2025 |
|
P160037
S023 |
Real-Time Process | BD Onclarity HPV Assay | BECTON, DICKINSON AND COMPANY |
07/02/2025 |
|
P220012
S052 |
30-Day Notice | Aurora EV-ICD System | Medtronic, Inc. | 07/02/2025 |
|
P220014
S005 |
Real-Time Process | CraniSeal Dural Sealant | Pramand, LLC | 07/02/2025 |
| P240040 | Original | Oncomine Dx Express Test | Life Technologies Corporation |
07/02/2025 |
|
P980016
S928 |
30-Day Notice | VIRTUSO/ENTRUST/MAXIMO/INT - RINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
07/02/2025 |
|
P980035
S816 |
30-Day Notice | MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE |
MEDTRONIC Inc. | 07/02/2025 |
|
P050017
S024 |
Panel Track | Zilver Flex(R) 35 Vascular Stent | Cook Ireland, Ltd. | 07/01/2025 |
|
P990065
S014 |
Panel Track | SIR-Spheres Y-90 Resin Microspheres | Sirtex Medical Pty Ltd | 07/01/2025 |
|
N970012
S208 |
30-Day Notice | AMS 700™ Inflatable Penile Prosthesis (IPP) With And Without InhibiZone |
Boston Scientific Corp. | 07/01/2025 |
|
P160054
S107 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 07/01/2025 |
|
P200031
S010 |
Real-Time Process | Organ Care System™ (OCS™) Liver | TransMedics, Inc. | 07/01/2025 |
|
P200035
S024 |
Real-Time Process | OrganOx Metra System | OrganOx Limited | 07/01/2025 |
|
P130022
S061 |
Normal 180 Day Track | Nevro Corp Senza Spinal Cord Stimulation (SCS) System |
Nevro Corporation | 06/30/2025 |
|
P160026
S061 |
30-Day Notice | LIFEPAK FLEX™ Lithium-ion Battery | Physio-Control. Inc. | 06/30/2025 |
|
P860003
S113 |
30-Day Notice | THERAKOS® CELLEX® Photopheresis System Procedural Kit |
Therakos Development Limited |
06/30/2025 |
|
P990009
S076 |
30-Day Notice | FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT |
BAXTER HEALTHCARE CORP. | 06/30/2025 |
|
P030036
S153 |
30-Day Notice | SelectSecure Lead | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/27/2025 |
|
P150013
S030 |
30-Day Notice | PD-L1 IHC 22C3 PHARMDX | Agilent Technologies, Inc. |
06/27/2025 |
|
P150025
S017 |
30-Day Notice | PD-L1 IHC 28-8 Pharmdx | Agilent Technologies, Inc. |
06/27/2025 |
|
P200039
S017 |
Real-Time Process | Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators |
Shockwave Medical, Inc. | 06/27/2025 |
|
P210011
S003 |
Real-Time Process | Xt CDx | Tempus Labs, Inc. | 06/27/2025 |
|
P230016
S002 |
30-Day Notice | MAGE-A4 IHC 1F9 Pharmdx | AGILENT TECHNOLOGIES, INC. |
06/27/2025 |
|
P230017
S007 |
Normal 180 Day Track No User Fee |
PulseSelect™ Pulsed Field Ablation (PFA) System |
Medtronic, Inc. | 06/27/2025 |
|
P230036
S011 |
Real-Time Process | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System |
Abbott Medical | 06/27/2025 |
|
P930039
S272 |
30-Day Notice | CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead |
Medtronic, Inc. | 06/27/2025 |
|
P050037
S146 |
30-Day Notice | RADIESSE® Injectable Implant | MERZ NORTH AMERICA, INC | 06/26/2025 |
|
P050052
S170 |
30-Day Notice | RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline |
MERZ NORTH AMERICA, INC | 06/26/2025 |
|
P100047
S230 |
30-Day Notice | HeartWare™ Ventricular Assist System (HVAD) |
Medtronic | 06/26/2025 |
|
P110023
S059 |
30-Day Notice | EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System |
MEDTRONIC VASCULAR INC | 06/26/2025 |
|
P140031
S190 |
30-Day Notice | Edwards Commander Delivery System | EDWARDS LIFESCIENCES, LLC. |
06/26/2025 |
|
P160043
S088 |
30-Day Notice | Resolute Onyx | MEDTRONIC VASCULAR | 06/26/2025 |
|
P170006
S036 |
30-Day Notice | Avalus Bioprosthesis, Model 400 | Medtronic Inc. | 06/26/2025 |
|
P170006
S037 |
30-Day Notice | Avalus Bioprosthesis, Model 400 | Medtronic Inc. | 06/26/2025 |
|
P170042
S013 |
30-Day Notice | Covera™ Vascular Covered Stents | C.R. Bard, Inc | 06/26/2025 |
|
P180003
S012 |
Normal 180 Day Track | BioMimics 3D Vascular Stent System | Veryan Medical Ltd. | 06/26/2025 |
