| PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
|---|---|---|---|---|
|
P100034
S040 |
30-Day Notice | Optune® | Novocure GmbH | 06/06/2025 |
|
P210025
S006 |
Normal 180 Day Track No User Fee |
SurVeil Drug-Coated Balloon | Surmodics, Inc. | 06/06/2025 |
|
P230013
S014 |
30-Day Notice | EVOQUE Tricuspid Valve Replacement System |
Edwards Lifesciences LLC | 06/06/2025 |
|
P010001
S030 |
30-Day Notice | Ceramic TRANSCEND® Hip Articulation System |
CERAMTEC GMBH | 06/05/2025 |
|
P010031
S879 |
135 Review Track For 30-Day Notice |
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/05/2025 |
|
P010031
S889 |
30-Day Notice | Amplia MRI CRTD DTMB1D1; Amplia MRI Quad CRT-D DTMB1Q1; Brava CRT-D DTBC1D1; Brava Quad CRTD DTBC1Q1; Claria MRI CRT-D D |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/05/2025 |
|
P020004
S200 |
30-Day Notice | GORE® EXCLUDER® AAA Endoprosthesis | W.L. GORE & ASSOCIATES,INC |
06/05/2025 |
|
P040037
S169 |
30-Day Notice | GORE® VIABAHN® Endoprosthesis | W.L. GORE & ASSOCIATES,INC |
06/05/2025 |
|
P040043
S142 |
30-Day Notice | Conformable GORE® TAG® Thoracic Endoprosthesis |
W. L. GORE & ASSOCIATES, INC. |
06/05/2025 |
|
P090013
S335 |
135 Review Track For 30-Day Notice |
CapSureFix MRI Lead | Medtronic, Inc | 06/05/2025 |
|
P100047
S229 |
30-Day Notice | HeartWare™ Ventricular Assist System (HVAD) |
Medtronic | 06/05/2025 |
|
P130006
S108 |
30-Day Notice | GORE® VIABAHN® Endoprosthesis With Heparin Bioactive Surface |
W.L. GORE & ASSOCIATES,INC |
06/05/2025 |
|
P200022
S016 |
135 Review Track For 30-Day Notice |
Simplify® Cervical Artificial Disc | NuVasive, Inc. | 06/05/2025 |
|
P200030
S020 |
30-Day Notice | GORE EXCLUDER Conformable AAA Endoprosthesis |
W. L. Gore and Associates, Inc. |
06/05/2025 |
|
P200030
S021 |
30-Day Notice | GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) |
W. L. Gore and Associates, Inc. |
06/05/2025 |
|
P210032
S021 |
30-Day Notice | GORE TAG Thoracic Branch Endoprosthesis |
W. L. Gore & Associates, Inc. |
06/05/2025 |
|
P230020
S004 |
30-Day Notice | Altius® Direct Electrical Nerve Stimulation System |
Neuros Medical, Inc. | 06/05/2025 |
|
P230023
S008 |
30-Day Notice | GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis |
W.L. Gore & Associates, Inc. |
06/05/2025 |
|
P240006
S008 |
30-Day Notice | VARIPULSE Bi-Directional Catheter | Biosense Webster, Inc | 06/05/2025 |
|
P930039
S268 |
135 Review Track For 30-Day Notice |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
Medtronic, Inc. | 06/05/2025 |
|
P980016
S913 |
135 Review Track For 30-Day Notice |
Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/05/2025 |
|
P980016
S923 |
30-Day Notice | Cobalt MRI ICD DDPB3D1; Cobalt MRI ICD DVPB3D1; Cobalt XT MRI ICD DDPA2D1; Cobalt XT MRI ICD DVPA2D1; Crome MRI ICD DDPC |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/05/2025 |
|
P010012
S590 |
30-Day Notice | NAV 2 Quadpole LV Long Spiral; NAV 2 Quadpole LV Straight; NAV 2 Quadpole LV Short Spiral |
Boston Scientific Corp. | 06/04/2025 |
|
P050010
S025 |
Normal 180 Day Track No User Fee |
PRODISC -L TOTAL DISC REPLACEMENT DEVICE |
Centinel Spine, LLC | 06/04/2025 |
|
P060040
S116 |
Real-Time Process | HeartMate II™ Left Ventricular Assist System |
Abbott Medical | 06/04/2025 |
|
P070001
S028 |
Normal 180 Day Track No User Fee |
Prodisc C, Prodisc C Vivo, Prodisc C Nova, Prodisc C SK |
Centinel Spine, LLC | 06/04/2025 |
|
P100018
S051 |
30-Day Notice | Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device With Shield Technology™ (Pipelin |
Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR |
06/04/2025 |
|
P100047
S228 |
30-Day Notice | HEARTWARE VENTRICULAR ASSIST SYSTEM | Medtronic | 06/04/2025 |
|
P110041
S014 |
Normal 180 Day Track | ADVIA Centaur HBsAgII (HBsII) | SIEMENS CORP. | 06/04/2025 |
|
P140031
S186 |
Normal 180 Day Track No User Fee |
Edwards Certitude Delivery System: 9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29 Ed |
EDWARDS LIFESCIENCES, LLC. |
06/04/2025 |
|
P160054
S101 |
Real-Time Process | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 06/04/2025 |
|
P180038
S024 |
Real-Time Process | LIAISON MUREX Anti-HBc And LIAISON MUREX Control Anti-HBc |
DiaSorin Inc. | 06/04/2025 |
|
P180047
S035 |
Real-Time Process | LIAISON QuantiFERON -TB Gold Plus And LIAISON Control QuantiFERON -TB Gold Plus |
DiaSorin, Inc. | 06/04/2025 |
|
P200015
S063 |
Normal 180 Day Track No User Fee |
Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29 |
Edwards Lifesciences, LLC |
06/04/2025 |
|
P220003
S022 |
Normal 180 Day Track No User Fee |
PASCAL Precision Implant System: 20000IS And 20000ISM PASCAL Precision Guide Sheath: 20000GS |
Edwards LifeSciences LLC | 06/04/2025 |
|
P220014
S007 |
30-Day Notice | CraniSeal Dural Sealant | Pramand, LLC | 06/04/2025 |
|
P230013
S012 |
Normal 180 Day Track No User Fee |
EVOQUE Tricuspid Delivery System: 9850TDS EVOQUE Dilator Kit: 9850DK EVOQUE Loading System: 9850LS |
Edwards Lifesciences LLC | 06/04/2025 |
|
P230042
S002 |
30-Day Notice | Optune Lua | Novocure GmbH | 06/04/2025 |
|
P240010
S003 |
Real-Time Process | MI Cancer Seek | Caris Life Sciences | 06/04/2025 |
|
P240027
S002 |
Real-Time Process | SpineSeal Spine Sealant | Pramand, LLC | 06/04/2025 |
|
P240036
S001 |
30-Day Notice | OmniaSecure™ MRI SureScan™ Lead Model 3930M |
Medtronic, Inc. | 06/04/2025 |
|
P910073
S181 |
30-Day Notice | Endotak Lead System | BOSTON SCIENTIFIC | 06/04/2025 |
|
P000053
S137 |
Real-Time Process | AMS 800 Artificial Urinary Sphincter (AUS) With And Without Lnhibizone |
Boston Scientific Corp. | 06/03/2025 |
|
P130005
S047 |
30-Day Notice | Diamondback 360 Coronary Orbital Atherectomy System; Diamondback 360 Precision Coronary Orbital Atherectomy System |
CARDIOVASCULAR SYSTEMS, INC. |
06/03/2025 |
|
P130008
S116 |
135 Review Track For 30-Day Notice |
Inspire Upper Airway Stimulation (UAS) |
INSPIRE MEDICAL SYSTEMS | 06/03/2025 |
|
P150038
S039 |
Real-Time Process | Exablate Model 4000 System Type 1.0 And 1.1 System (“Exablate Neuro”; “Exablate Prime”) |
InSightec | 06/03/2025 |
|
P170038
S024 |
30-Day Notice | CentriMag Circulatory Support System | Abbott | 06/02/2025 |
|
P200035
S019 |
Normal 180 Day Track | OrganOx Metra® System | OrganOx Limited | 06/02/2025 |
|
P220020
S006 |
30-Day Notice | Lava Liquid Embolic System (Lava LES) |
BlackSwan Vascular, Inc. | 06/02/2025 |
|
BP170122
1115 |
30-Day Notice | ReCell Autologous Cell Harvesting Device |
Avita Medical | 05/30/2025 |
|
P010015
S562 |
30-Day Notice | Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser |
MEDTRONIC Inc. | 05/30/2025 |
|
P010030
S191 |
Real-Time Process | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST |
ZOLL MANUFACTURING CORPORATION |
05/30/2025 |
|
P010030
S193 |
30-Day Notice | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST |
ZOLL MANUFACTURING CORPORATION |
05/30/2025 |
|
P020018
S064 |
Panel Track | Zenith® Iliac Branch | COOK, INC. | 05/30/2025 |
|
P130008
S125 |
30-Day Notice | INSPIRE II UPPER AIRWAY STIMULATOR | INSPIRE MEDICAL SYSTEMS | 05/30/2025 |
|
P160015
S022 |
30-Day Notice | AED 3 Semi-Automatic, AED 3 Fully Automatic |
ZOLL MEDICAL CORPORATION | 05/30/2025 |
|
P160022
S044 |
30-Day Notice | AED 3 BLS | ZOLL MEDICAL CORPORATION | 05/30/2025 |
|
P170008
S057 |
30-Day Notice | EluNIR™ Ridaforolimus Eluting Coronary Stent System |
Medinol, Ltd. | 05/30/2025 |
|
P170024
S023 |
30-Day Notice | Surpass Streamline Flow Diverter | Stryker Neurovascular | 05/30/2025 |
|
P170034
S015 |
30-Day Notice | Hydrus® Microstent | Ivantis, Inc. wholly-owned subsidiary of Alcon Research, LLC |
05/30/2025 |
|
P200039
S016 |
30-Day Notice | Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter |
Shockwave Medical, Inc. | 05/30/2025 |
|
P200041
S008 |
30-Day Notice | Scoreflex NC Scoring PTCA Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. |
05/30/2025 |
|
P210007
S006 |
30-Day Notice | Vivistim® System | MicroTransponder, Inc. | 05/30/2025 |
|
P220012
S050 |
30-Day Notice | Epsila EV Extravascular Lead (EV2401) |
Medtronic, Inc. | 05/30/2025 |
|
P240005
S004 |
30-Day Notice | Envista Envy™ Hydrophobic Acrylic Intraocular Lens (IOL), Envista Envy™ Toric Hydrophobic Acrylic Intraocular Lens (IOL) |
Bausch & Lomb, Inc. | 05/30/2025 |
|
P240013
S007 |
Normal 180 Day Track No User Fee |
Sphere-9 Catheter And Affera Ablation System |
Medtronic Inc. | 05/30/2025 |
|
P910056
S059 |
30-Day Notice | Envista Hydrophobic Acrylic Intraocular Lens (IOL), Envista Toric Hydrophobic Acrylic Intraocular Lens (IOL), Envista As |
Bausch & Lomb, Inc. | 05/30/2025 |
|
P920015
S299 |
30-Day Notice | HV Splitter/Adaptor Kit (5019); Sprint Quattro Lead (6947M); Sprint Quattro Lead (6946M); Sprint Quattro Lead (6935M) |
MEDTRONIC Inc. | 05/30/2025 |
|
P980035
S811 |
30-Day Notice | Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 Astra S DR MRI IPG X3DR01 Astra S SR MRI IPG X3SR |
MEDTRONIC Inc. | 05/30/2025 |
|
P140010
S092 |
30-Day Notice | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C |
MEDTRONIC Inc. | 05/29/2025 |
|
P150031
S085 |
Special (Immediate Track) |
VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM |
Boston Scientific Corp. | 05/29/2025 |
|
P190008
S039 |
30-Day Notice | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Medtronic Vascular Inc. | 05/29/2025 |
|
P200022
S017 |
30-Day Notice | Simplify® Cervical Artificial Disc | NuVasive, Inc. | 05/29/2025 |
|
P200041
S007 |
30-Day Notice | Scoreflex NC Scoring PTCA Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. |
05/29/2025 |
|
P220002
S008 |
30-Day Notice | TOPS™ System | Premia Spine Ltd. | 05/29/2025 |
|
P220014
S006 |
30-Day Notice | CraniSeal Dural Sealant | Pramand, LLC | 05/29/2025 |
|
P980040
S173 |
30-Day Notice | Intraocular Lenses (IOLs) In The DaisyWheel And TECNIS SIMPLICITY Delivery System |
Johnson & Johnson Surgical Vision, Inc. |
05/29/2025 |
|
N970012
S207 |
30-Day Notice | AMS 700™ Inflatable Penile Prosthesis Without InhibiZone™ |
Boston Scientific Corp. | 05/28/2025 |
|
P000006
S070 |
Normal 180 Day Track No User Fee |
Titan Inflatable Penile Prosthesis | COLOPLAST CORP. | 05/28/2025 |
|
P000053
S139 |
30-Day Notice | AMS 800™ Artificial Urinary Sphincter (AUS) |
Boston Scientific Corp. | 05/28/2025 |
|
P010029
S041 |
30-Day Notice | EUFLEXXA (1% SODIUM HYALURONATE) | FERRING PHARMACEUTICALS, INC. |
05/28/2025 |
|
P010031
S890 |
30-Day Notice | Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI C |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
05/28/2025 |
|
P020036
S055 |
Special (Immediate Track) |
S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM |
Cordis US Corporation | 05/28/2025 |
|
P040045
S140 |
30-Day Notice | VISTAKON® (senofilcon A) Brand Contact Lenses |
VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR |
05/28/2025 |
|
P060019
S057 |
30-Day Notice | IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF |
IRVINE BIOMEDICAL, INC. | 05/28/2025 |
|
P120002
S030 |
Special (Immediate Track) |
SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS |
Cordis US Corporation | 05/28/2025 |
|
P900056
S220 |
30-Day Notice | ROTAPRO™ Rotational Atherectomy System |
Boston Scientific Corp. | 05/28/2025 |
|
P980016
S924 |
30-Day Notice | Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1; Cobalt XT MRI ICD |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
05/28/2025 |
|
P990040
S035 |
30-Day Notice | TRUFILL N-bca Liquid Embolic System (LES) And Procedural Set |
Cerenovus, Inc. | 05/28/2025 |
|
P000027
S043 |
30-Day Notice | ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK |
ROCHE DIAGNOSTICS CORP. | 05/27/2025 |
|
P130022
S066 |
Normal 180 Day Track No User Fee |
Senza Spinal Cord Stimulation (SCS) System |
Nevro Corporation | 05/27/2025 |
|
P190002
S037 |
Real-Time Process | Saluda Medical Evoke SCS System | SALUDA MEDICAL PTY LTD | 05/27/2025 |
|
P990004
S074 |
30-Day Notice | SURGIFOAM® Absorbable Gelatin Sponge |
Ferrosan Meidcal Devices A/S |
05/27/2025 |
|
P990056
S044 |
30-Day Notice | ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET |
ROCHE DIAGNOSTICS CORP. | 05/27/2025 |
|
BP120001
S753 |
30-Day Notice | OraQuick® In-Home HIV Test | OraSure Technologies, Inc |
05/27/2025 |
| P240042 | Original | Tendyne Transcatheter Mitral Valve System |
Abbott Medical | 05/23/2025 |
|
P000013
S026 |
Special (Immediate Track) |
Trident Acetabular System: Trident Alumina Inserts |
HOWMEDICA OSTEONICS CORP. |
05/23/2025 |
|
P040029
S023 |
Normal 180 Day Track | Euclid Orthokeratology (oprifocon A) Contact Lenses For Overnight Wear And Euclid Orthokeratology (tisilfocon A) Contact |
Euclid Vision Corporation |
05/23/2025 |
|
P060004
S009 |
Real-Time Process | MEL 90 EXCIMER LASER SYSTEM | Carl Zeiss Meditec, Inc. | 05/23/2025 |
|
P060040
S115 |
Normal 180 Day Track | HeartMate II Left Ventricular Assist System |
Abbott Medical | 05/23/2025 |
|
P160054
S100 |
Normal 180 Day Track | HeartMate 3 Left Ventricular Assist System |
Abbott Medical | 05/23/2025 |
|
P180050
S014 |
Real-Time Process | Barostim System | CVRx, INC. | 05/23/2025 |
|
P000021
S047 |
30-Day Notice | Dimension TPSA Flex Reagent Cartridge |
SIEMENS HEALTHCARE DIAGNOSTICS |
05/22/2025 |
|
P010054
S048 |
30-Day Notice | Elecsys Anti-HBs | ROCHE DIAGNOSTICS CORP. | 05/22/2025 |
|
P020027
S042 |
30-Day Notice | Dimension FPSA Flex Reagent Cartridge |
SIEMENS HEALTHCARE DIAGNOSTICS |
05/22/2025 |
|
P030035
S209 |
30-Day Notice | Allure RF, Quadra Allure, Quadra Allure MP, Quadra Allure MP RF |
Abbott Medical | 05/22/2025 |
|
P030054
S434 |
30-Day Notice | Avant HF, Avant HF, Gallant HF, Entrant HF, Quadra Assura MP, Quadra Assura, Unify Assura, Quartet, QuickFlex Micro |
Abbott Medical | 05/22/2025 |
|
P100031
S033 |
30-Day Notice | Elecsys Anti-HBc II | ROCHE DIAGNOSTICS CORP. | 05/22/2025 |
|
P100032
S023 |
30-Day Notice | Elecsys Anti-HBc II | ROCHE DIAGNOSTICS CORP. | 05/22/2025 |
|
P110022
S034 |
30-Day Notice | Elecsys Anti-HBc IgM | ROCHE DIAGNOSTICS CORP. | 05/22/2025 |
|
P110031
S027 |
30-Day Notice | Elecsys Anti-HBc IgM | ROCHE DIAGNOSTICS CORP. | 05/22/2025 |
|
P130015
S022 |
30-Day Notice | Elecsys HBeAg | ROCHE DIAGNOSTICS OPERATIONS INC |
05/22/2025 |
|
P140033
S097 |
30-Day Notice | Endurity MRI, Assurity MRI | Abbott Medical | 05/22/2025 |
|
P150035
S025 |
30-Day Notice | Aveir VR | Abbott Medical | 05/22/2025 |
|
P160019
S019 |
30-Day Notice | Elecsys HBsAg II/Elecsys HBsAg Auto Confirm |
ROCHE DIAGNOSTICS, INC. | 05/22/2025 |
|
P170023
S021 |
30-Day Notice | Bulkamid Urethral Bulking System | Boston Scientific Corporation |
05/22/2025 |
|
P190005
S007 |
30-Day Notice | Elecsys Anti-HBe | Roche Diagnostics | 05/22/2025 |
|
P190034
S010 |
30-Day Notice | Elecsys Anti-HBs II, PreciControl Anti-HBs |
Roche Diagnostics | 05/22/2025 |
|
P240013
S006 |
30-Day Notice | Sphere-9 Ablation And Mapping Catheter - AFR-00001 |
Medtronic Inc. | 05/22/2025 |
|
P880086
S343 |
30-Day Notice | Zephyr XL DR, Zephyr DR, Zephyr SR, Zephyr XL SR, Verity ADX XL VDR |
Abbott Medical | 05/22/2025 |
|
P910023
S478 |
30-Day Notice | Avant VR, Avant DR, Neutrino NxT VR, Neutrino NxT DR, Gallant VR, Gallant DR, Entrant VR, Entrant DR, Ellipse VR, Ellips |
Abbott Medical | 05/22/2025 |
|
P950022
S147 |
30-Day Notice | Durata, Optisure | Abbott Medical | 05/22/2025 |
|
P960013
S128 |
30-Day Notice | Tendril STS, Optisense | Abbott Medical | 05/22/2025 |
|
P960030
S079 |
30-Day Notice | IsoFlex | Abbott Medical | 05/22/2025 |
|
P970013
S098 |
30-Day Notice | Microny II SR+ | Abbott Medical | 05/22/2025 |
|
P030053
S079 |
30-Day Notice | MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS |
MENTOR CORP. | 05/21/2025 |
|
P060028
S054 |
30-Day Notice | MENTOR MEMORYSHAPE BREAST IMPLANTS | MENTOR WORLDWIDE LLC | 05/21/2025 |
|
P060040
S119 |
30-Day Notice | THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM |
Abbott Medical | 05/21/2025 |
|
P080025
S317 |
30-Day Notice | InterStim® Therapy System, Verify® Evaluation System |
MEDTRONIC NEUROMODULATION |
05/21/2025 |
|
P160054
S106 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 05/21/2025 |
|
P830055
S344 |
30-Day Notice | LCS® Total Knee System - MBT Thick Tray |
DEPUY, INC. | 05/21/2025 |
|
P840001
S593 |
30-Day Notice | Master Restore, Itrel®, Synergy®, Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify®, |
MEDTRONIC NEUROMODULATION |
05/21/2025 |
|
P860004
S442 |
30-Day Notice | SynchroMed® Infusion System, Ascenda ® Intrathecal Catheters |
MEDTRONIC Inc. | 05/21/2025 |
|
P960009
S505 |
30-Day Notice | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense TM |
MEDTRONIC Inc. | 05/21/2025 |
|
P970004
S422 |
30-Day Notice | InterStim® Therapy System,Verify® Evaluation System |
MEDTRONIC NEUROMODULATION |
05/21/2025 |
|
P990075
S062 |
30-Day Notice | MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES |
MENTOR WORLDWIDE LLC | 05/21/2025 |
|
N17600
S044 |
30-Day Notice | Avitene™ Microfibrillar Collagen Hemostat |
DAVOL, INC., SUB. C.R. BARD, INC. |
05/20/2025 |
|
P080011
S188 |
30-Day Notice | Biofinity Sphere And Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses Extended Wear |
CooperVision, Inc. | 05/20/2025 |
|
P100040
S072 |
30-Day Notice | Valiant Thoracic Stent Graft With The Captivia Delivery System |
Medtronic Vascular | 05/20/2025 |
|
P130018
S003 |
30-Day Notice | ProACT Adjustable Continence Therapy For Men |
UROMEDICA INC | 05/20/2025 |
|
P140005
S006 |
30-Day Notice | GenVisc 850 | ORTHOGENRX,INC | 05/20/2025 |
|
P140018
S044 |
Normal 180 Day Track | VenaSeal Closure System | MEDTRONIC VASCULAR INC | 05/20/2025 |
|
P140031
S188 |
30-Day Notice | SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES |
EDWARDS LIFESCIENCES, LLC. |
05/20/2025 |
|
P150031
S083 |
Real-Time Process | Vercise Genus, Vercise Gevia, Vercise PC, Vercise DBS Systems |
Boston Scientific Corp. | 05/20/2025 |
|
P160021
S047 |
Normal 180 Day Track | Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis (RP VBX Device) |
W. L. Gore & Associates, Inc. |
05/20/2025 |
|
P160057
S003 |
30-Day Notice | TriVisc | ORTHOGENRX,INC | 05/20/2025 |
|
P170023
S022 |
30-Day Notice | Bulkamid Urethral Bulking System | Boston Scientific Corporation |
05/20/2025 |
|
P200015
S065 |
30-Day Notice | Edwards SAPIEN 3 Transcatheter Heart Valve System With Edwards Commander Delivery System |
Edwards Lifesciences, LLC |
05/20/2025 |
|
P230023
S006 |
Normal 180 Day Track | GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) |
W.L. Gore & Associates, Inc. |
05/20/2025 |
|
P900056
S219 |
30-Day Notice | ROTAPRO™ Rotational Atherectomy System |
Boston Scientific Corp. | 05/20/2025 |
|
P110019
S135 |
Real-Time Process | Xience Skypoint Everolimus Eluting Coronary Stent System; XIENCE Alpine Everolimus Coronary Stent System; XIENCE Sierra |
ABBOTT VASCULAR | 05/19/2025 |
|
P160055
S044 |
Real-Time Process | Light Adjustable Lens And Light Delivery Device |
RxSight, Inc. | 05/19/2025 |
|
P180001
S015 |
Normal 180 Day Track No User Fee |
Zenith Dissection Endovascular System |
WILLIAM COOK EUROPE APS | 05/19/2025 |
|
P100009
S074 |
30-Day Notice | MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System |
Abbott Medical | 05/18/2025 |
|
P230007
S012 |
30-Day Notice | TriClip G4 Delivery System;TriClip G5 Delivery System |
Abbott Medical | 05/18/2025 |
|
P010032
S235 |
30-Day Notice | SCS System | Abbott Medical | 05/16/2025 |
|
P130008
S122 |
30-Day Notice | INSPIRE II UPPER AIRWAY STIMULATOR | INSPIRE MEDICAL SYSTEMS | 05/16/2025 |
|
P140009
S117 |
30-Day Notice | DBS System | Abbott Medical | 05/16/2025 |
|
P190031
S012 |
Normal 180 Day Track | VENTANA HER2 Dual ISH DNA Probe Cocktail |
Ventana Medical Systems, Inc. |
05/16/2025 |
|
P020036
S056 |
30-Day Notice | S.M.A.R.T.® CONTROL® Nitinol Stent System, S.M.A.R.T. RADIANZTM Vascular Stent System |
Cordis US Corporation | 05/15/2025 |
|
P100013
S030 |
30-Day Notice | EXOSEAL® Vascular Closure Device | Cordis US Corporation | 05/15/2025 |
|
P100045
S081 |
30-Day Notice | CardioMEMS HF System | Abbott Medical | 05/15/2025 |
|
P120002
S031 |
30-Day Notice | S.M.A.R.T.® And S.M.A.R.T.® CONTROL® Vascular Stent Systems, S.M.A.R.T. RADIANZ™ Vascular Stent System |
Cordis US Corporation | 05/15/2025 |
|
P150002
S012 |
30-Day Notice | INCRAFT® AAA Stent Graft System | Cordis US Corporation | 05/15/2025 |
|
P170030
S054 |
30-Day Notice | Orsiro Mission Sirolimus Eluting Coronary Stent System |
Biotronik, Inc | 05/15/2025 |
|
P220012
S044 |
Real-Time Process | Epsila EV Transverse Tunneling Tool | Medtronic, Inc. | 05/15/2025 |
| P240004 | Original | EndoForce Connector For Endovascular Venous Anastomosis |
Phraxis, Inc. | 05/15/2025 |
|
P900060
S068 |
Normal 180 Day Track | CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V |
CORCYM S.r.l. | 05/15/2025 |
|
P970038
S046 |
Normal 180 Day Track | Access Hybritech Free PSA | BECKMAN COULTER, INC. | 05/15/2025 |
| P240037 | Original | VENTANA MET (SP44) RxDx Assay | Ventana Medical Systems Inc (Roche Tissue Diagnostics) |
05/14/2025 |
|
P080006
S191 |
30-Day Notice | MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD |
MEDTRONIC Inc. | 05/14/2025 |
|
P180035
S027 |
30-Day Notice | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses For Daily Wear |
CooperVision, Inc. | 05/14/2025 |
|
P230001
S005 |
Normal 180 Day Track | ColoSense | Geneoscopy, Inc. | 05/14/2025 |
|
P010030
S192 |
30-Day Notice | LifeVest® Wearable Defibrillator | ZOLL MANUFACTURING CORPORATION |
05/13/2025 |
|
P080025
S318 |
30-Day Notice | InterStimTM Therapy System, Verify® Evaluation System |
MEDTRONIC NEUROMODULATION |
05/13/2025 |
|
P200046
S041 |
30-Day Notice | Harmony™ Transcatheter Pulmonic Valve System |
Medtronic, Inc. | 05/13/2025 |
|
P230040
S013 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 05/13/2025 |
|
P230040
S014 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 05/13/2025 |
|
P970004
S423 |
30-Day Notice | InterStimTM Therapy System, Verify® Evaluation System |
MEDTRONIC NEUROMODULATION |
05/13/2025 |
|
P100026
S098 |
Real-Time Process | NEUROPACE RNS SYSTEM | NEUROPACE INC | 05/12/2025 |
|
P160055
S048 |
30-Day Notice | Light Adjustable Lens And Light Delivery Device |
RxSight, Inc. | 05/12/2025 |
|
P010047
S070 |
30-Day Notice | PROGEL Pleural Air Leak Sealant | NEOMEND, INC. | 05/09/2025 |
|
P040044
S109 |
Special (Immediate Track) |
Mynx Control Vascular Closure Device | Cordis US Corporation | 05/09/2025 |
|
P060001
S047 |
30-Day Notice | PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS |
MEDTRONIC VASCULAR INC | 05/09/2025 |
|
P100009
S071 |
Real-Time Process | MITRACLIP DELIVERY SYSTEM | Abbott Medical | 05/09/2025 |
|
P110023
S058 |
30-Day Notice | EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent With Entrust™ Delivery Syste |
MEDTRONIC VASCULAR INC | 05/09/2025 |
|
P130008
S121 |
30-Day Notice | INSPIRE II UPPER AIRWAY STIMULATOR | INSPIRE MEDICAL SYSTEMS | 05/09/2025 |
|
P150016
S025 |
30-Day Notice | TRIDYNE™ Vascular Sealant | NEOMEND, INC. | 05/09/2025 |
|
P160017
S123 |
Real-Time Process | MiniMed 770G Insulin Pump; MiniMed 780G Insulin Pump |
MEDTRONIC MINIMED, INC. | 05/09/2025 |
|
P160028
S006 |
Special (Immediate Track) |
HeartStart FR3 Defibrillator | PHILIPS MEDICAL SYSTEMS, INC. |
05/09/2025 |
|
P180028
S015 |
Special (Immediate Track) |
HeartStart FRx Defibrillator | Philips Medical Systems | 05/09/2025 |
|
P180031
S011 |
30-Day Notice | Neuroform Atlas Stent System | Stryker Neurovascular | 05/09/2025 |
|
P230007
S010 |
Real-Time Process | TriClip G4 System | Abbott Medical | 05/09/2025 |
|
P240006
S001 |
Normal 180 Day Track No User Fee |
VARIPULSE (TM) Catheter; TRUPULSE (TM) Generator; Sterile Interface Cable; Ngen (TM) Pump |
Biosense Webster, Inc | 05/09/2025 |
|
P890055
S089 |
Special (Immediate Track) |
Intera 3000 Hepatic Artery Infusion Pump |
Intera Oncology | 05/09/2025 |
|
P060040
S118 |
30-Day Notice | HeartMate II™ Left Ventricular Assist System |
Abbott Medical | 05/08/2025 |
|
P100021
S125 |
Normal 180 Day Track No User Fee |
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System |
Medtronic Vascular | 05/08/2025 |
|
P100040
S069 |
Normal 180 Day Track No User Fee |
Valiant Thoracic Stent Graft With The Captiva Delivery System |
Medtronic Vascular | 05/08/2025 |
|
P110033
S098 |
Special (Immediate Track) |
JUVEDERM VOLUMA XC | Allergan | 05/08/2025 |
|
P160054
S105 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System (LVAS) |
Abbott Medical | 05/08/2025 |
