| PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
|---|---|---|---|---|
|
P020036
S057 |
30-Day Notice | S.M.A.R.T.® CONTROL® Nitinol Stent System |
Cordis US Corporation | 09/12/2025 |
|
P030047
S051 |
30-Day Notice | PRECISE® PRO RX Nitinol Stent System; PRECISE® PRO Transcarotid Stent System |
Cordis US Corporation | 09/12/2025 |
|
P120002
S032 |
30-Day Notice | S.M.A.R.T.® CONTROL® Vascular Stent System |
Cordis US Corporation | 09/12/2025 |
|
P120003
S011 |
30-Day Notice | Icast Covered Stent System | ATRIUM MEDICAL CORP. | 09/12/2025 |
|
P140002
S030 |
30-Day Notice | MISAGO® RX Self-expanding Peripheral Stent |
TERUMO MEDICAL CORPORATION |
09/12/2025 |
|
P160007
S055 |
30-Day Notice | Simplera System | MEDTRONIC MINIMED | 09/12/2025 |
|
P160017
S128 |
30-Day Notice | MiniMed 780G System | MEDTRONIC MINIMED, INC. | 09/12/2025 |
|
P160035
S049 |
Normal 180 Day Track | EXCOR Cannula Clip | Berlin Heart Inc. | 09/12/2025 |
|
P230013
S018 |
30-Day Notice | Edwards EVOQUE Tricuspid Delivery System |
Edwards Lifesciences LLC | 09/12/2025 |
|
P250012
S003 |
30-Day Notice | Simplera Sync Sensor, Guardian 4 Sensor |
Medtronic MiniMed Inc. | 09/12/2025 |
|
P970003
S250 |
30-Day Notice | VNS Therapy® System | LivaNova USA, Inc. | 09/12/2025 |
|
P050023
S200 |
30-Day Notice | Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 |
BIOTRONIK, INC. | 09/11/2025 |
|
P070008
S169 |
30-Day Notice | Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8 HF-T QP (4071 |
BIOTRONIK, INC. | 09/11/2025 |
|
P220012
S054 |
Real-Time Process | Aurora EV-ICD System | Medtronic, Inc. | 09/11/2025 |
|
P220023
S009 |
30-Day Notice | ReCor Paradise™ Catheter | ReCor Medical, Inc. | 09/11/2025 |
|
P240003
S004 |
Special (Immediate Track) |
Minima Stent System | Renata Medical, Inc. | 09/11/2025 |
|
P950037
S275 |
30-Day Notice | Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En |
BIOTRONIK, INC. | 09/11/2025 |
|
P980040
S174 |
Real-Time Process | TECNIS Odyssey IOL With TECNIS SIMPLICITY Delivery System (DRN00V); TECNIS Odyssey Toric II IOLs With TECNIS SIMPLICITY |
Johnson & Johnson Surgical Vision, Inc. |
09/11/2025 |
|
P080010
S027 |
Normal 180 Day Track No User Fee |
TECNIS Multifocal 3-Piece IOL | Johnson & Johnson Surgical Vision, Inc. |
09/10/2025 |
|
P080025
S316 |
135 Review Track For 30-Day Notice |
InterStim® Therapy System | MEDTRONIC NEUROMODULATION |
09/10/2025 |
|
P100045
S084 |
30-Day Notice | CardioMEMSTM HF System | Abbott Medical | 09/10/2025 |
|
P200045
S020 |
30-Day Notice | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | 09/10/2025 |
|
P230003
S006 |
Panel Track | Alinity M HR HPV | Abbott Molecular, Inc | 09/10/2025 |
|
P230040
S019 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 09/10/2025 |
|
P240006
S011 |
30-Day Notice | VARIPULSE™ Catheter | Biosense Webster, Inc | 09/10/2025 |
| P240038 | Original | FINEVISION HP Trifocal IOLs | Beaver Visitec International, Inc. |
09/10/2025 |
|
P970004
S421 |
135 Review Track For 30-Day Notice |
InterStim® Therapy System | MEDTRONIC NEUROMODULATION |
09/10/2025 |
|
P980040
S171 |
Normal 180 Day Track No User Fee |
SENSAR Soft Acrylic Posterior Chamber IOL, SENSAR 1-piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS |
Johnson & Johnson Surgical Vision, Inc. |
09/10/2025 |
|
P990080
S062 |
Normal 180 Day Track No User Fee |
TECNIS Foldable Acrylic IOL With OptiEdge |
Johnson & Johnson Surgical Vision, Inc. |
09/10/2025 |
|
BP953200
S132 |
30-Day Notice | Apligraf | Organogenesis, Inc. | 09/10/2025 |
|
N12159
S123 |
30-Day Notice | SURGICEL BRAND ABSORBABLE HEMOSTAT | ETHICON, INC. | 09/09/2025 |
|
P010031
S897 |
Normal 180 Day Track No User Fee |
Cardiac Resynchronization Therapy -Defibrillator (CRT-D) |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
09/09/2025 |
|
P020004
S203 |
30-Day Notice | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
W.L. GORE & ASSOCIATES,INC |
09/09/2025 |
|
P040043
S145 |
30-Day Notice | Conformable GORE® TAG® Thoracic Endoprosthesis |
W. L. GORE & ASSOCIATES, INC. |
09/09/2025 |
|
P210032
S023 |
30-Day Notice | GORE® TAG® Thoracic Branch Endoprosthesis |
W. L. Gore & Associates, Inc. |
09/09/2025 |
|
P220003
S025 |
30-Day Notice | PASCAL Precision Transcatheter Valve Repair System |
Edwards LifeSciences LLC | 09/09/2025 |
|
P230023
S009 |
30-Day Notice | GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis |
W.L. Gore & Associates, Inc. |
09/09/2025 |
| P240015 | Original | Womed Leaf Resorbable Adhesion Barrier |
WOMED SAS | 09/09/2025 |
|
P830055
S349 |
30-Day Notice | LCS® Total Knee System | DEPUY, INC. | 09/09/2025 |
|
P900033
S115 |
30-Day Notice | INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, And Integra® Omnigraft Dermal Regen |
Integra LifeSciences Corp. |
09/09/2025 |
|
P980016
S931 |
Normal 180 Day Track No User Fee |
Implantable Cardioverter Defibrillator (ICD) |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
09/09/2025 |
|
P200035
S029 |
30-Day Notice | OrganOx Metra® System | OrganOx Limited | 09/08/2025 |
| P240008 | Original | Saypha® MagIQ™ | CROMA-PHARMA GmbH | 09/08/2025 |
|
P990004
S076 |
30-Day Notice | SURGIFOAM® Absorbable Gelatin Sponge |
Ferrosan Meidcal Devices A/S |
09/08/2025 |
|
P010032
S240 |
Normal 180 Day Track | Eterna™ SCS IPG | Abbott Medical | 09/07/2025 |
|
P140009
S121 |
Normal 180 Day Track | Liberta RC™ DBS IPG | Abbott Medical | 09/07/2025 |
|
P010015
S570 |
30-Day Notice | Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C |
MEDTRONIC Inc. | 09/05/2025 |
|
P010031
S901 |
30-Day Notice | Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
09/05/2025 |
|
P080025
S329 |
30-Day Notice | InterStim® Therapy System; Verify® Evaluation System |
MEDTRONIC NEUROMODULATION |
09/05/2025 |
|
P150033
S216 |
30-Day Notice | Miera AV TPS (MC1AVR1); Miera A V2 TPS (MC2AVR1); Miera TPS (MC1VR01); Miera VR2 TPS (MC2VR01) |
MEDTRONIC Inc. | 09/05/2025 |
|
P150035
S031 |
Normal 180 Day Track No User Fee |
AVEIR Leadless Pacemaker | Abbott Medical | 09/05/2025 |
|
P180028
S017 |
30-Day Notice | HeartStart FRx Defibrillator And HeartStart SMART Pads II |
Philips Medical Systems | 09/05/2025 |
|
P200046
S043 |
Special (Immediate Track) |
Harmony™ TPV System | Medtronic, Inc. | 09/05/2025 |
|
P220012
S057 |
30-Day Notice | Aurora EV-ICD System (DVEA3E4) | Medtronic, Inc. | 09/05/2025 |
|
P230011
S004 |
30-Day Notice | TruSight Oncology Comprehensive | Illumina, Inc. | 09/05/2025 |
|
P240020
S001 |
Normal 180 Day Track No User Fee |
TOUCH® CMC 1 Prosthesis | Keri Medical SA | 09/05/2025 |
|
P240020
S002 |
Normal 180 Day Track No User Fee |
TOUCH® CMC 1 Prosthesis | Keri Medical SA | 09/05/2025 |
|
P840001
S605 |
30-Day Notice | Master Restore, Itrel®, Synergy IntellisTM, VantaTM And InceptivTM Spinal Cord Stimulation Systems And PiscesTM, Specify |
MEDTRONIC NEUROMODULATION |
09/05/2025 |
|
P860004
S449 |
30-Day Notice | SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
MEDTRONIC Inc. | 09/05/2025 |
|
P930021
S034 |
30-Day Notice | Straumann Emdogain | THE STRAUMANN COMPANY | 09/05/2025 |
|
P960009
S517 |
30-Day Notice | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 09/05/2025 |
|
P970003
S248 |
Special (Immediate Track) |
VNS Therapy System | LivaNova USA, Inc. | 09/05/2025 |
|
P970004
S434 |
30-Day Notice | InterStim® Therapy System; Verify® Evaluation System |
MEDTRONIC NEUROMODULATION |
09/05/2025 |
|
P980016
S935 |
30-Day Notice | Percepta Bipolar CRT-P W1TR1; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Serena Quadripolar CRT-P W |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
09/05/2025 |
|
P980035
S821 |
30-Day Notice | Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az |
MEDTRONIC Inc. | 09/05/2025 |
|
N12159
S124 |
30-Day Notice | SURGICEL® Absorbable Hemostats | ETHICON, INC. | 09/04/2025 |
|
P130013
S077 |
Real-Time Process | WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY |
Boston Scientific Corp. | 09/04/2025 |
|
P130024
S044 |
30-Day Notice | Lutonix 035 (Model 9004 And Model 9010) |
LUTONIX | 09/04/2025 |
|
P170003
S028 |
30-Day Notice | Lutonix 018 (Model 9014) | LUTONIX | 09/04/2025 |
|
P190024
S015 |
30-Day Notice | CINtec PLUS Cytology | Ventana Medical Systems, Inc. |
09/04/2025 |
|
P240013
S010 |
Real-Time Process | Sphere-9™ Mapping And Ablation Catheter |
Medtronic Inc. | 09/04/2025 |
|
P880047
S065 |
30-Day Notice | GYNECARE INTERCEED™ Absorbable Adhesion Barrier |
ETHICON, INC. | 09/04/2025 |
|
P010012
S591 |
Real-Time Process | ACUITY X4 Straight, Models 4671 And 4672; ACUITY X4 Spiral S, Models 4674 And 4675; ACUITY X4 Spiral L, Models 4677 And |
Boston Scientific Corp. | 09/03/2025 |
|
P110038
S034 |
30-Day Notice | RelayPlus | BOLTON MEDICAL, INC. | 09/03/2025 |
|
P190015
S025 |
30-Day Notice | TREO® Abdominal Stent-Graft System | Bolton Medical Inc. | 09/03/2025 |
|
P200045
S019 |
30-Day Notice | RelayPro | Bolton Medical, Inc. | 09/03/2025 |
|
P210007
S007 |
30-Day Notice | Vivistim® System | MicroTransponder, Inc. | 09/03/2025 |
|
P220020
S005 |
Normal 180 Day Track No User Fee |
Lava Liquid Embolic System (Lava LES) And Lava Mixing Kit |
BlackSwan Vascular, Inc. | 09/03/2025 |
|
P240022
S001 |
Normal 180 Day Track No User Fee |
EVOLYSSE® FORM And EVOLYSSE® SMOOTH |
Symatese | 09/03/2025 |
|
P240028
S002 |
30-Day Notice | WiSE® (Wireless Stimulation Of The Endocardium Technology) CRT System |
EBR Systems, Inc. | 09/03/2025 |
|
P050010
S027 |
Normal 180 Day Track No User Fee |
PRODISC L | Centinel Spine, LLC | 09/02/2025 |
|
P080010
S029 |
30-Day Notice | TECNIS 3-Piece Multifocal, Model ZMA00 |
Johnson & Johnson Surgical Vision, Inc. |
09/02/2025 |
|
P150005
S088 |
Normal 180 Day Track No User Fee |
Opal HDx Ablation Connection Box (Maestro); Opal HDx Ablation Connection Box - IntellaNav StablePoint; Opal HDx Ablation |
Boston Scientific Corp. | 09/02/2025 |
|
P160008
S029 |
Special (Immediate Track) |
HeartSine’s Samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P And SAM 450P) And Accessories |
HeartSine Technologies, Ltd. |
09/02/2025 |
|
P160055
S045 |
Normal 180 Day Track No User Fee |
LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) |
RxSight, Inc. | 09/02/2025 |
|
P970051
S237 |
Normal 180 Day Track No User Fee |
Cochlear™ Nucleus® System | Cochlear Americas | 09/02/2025 |
|
P980040
S177 |
30-Day Notice | TECNIS™ Toric II 1-Piece IOLs, ZCU TECNIS Symfony Toric II Extended Range Of Vision IOLs, ZXU TECNIS Eyhance Toric II IO |
Johnson & Johnson Surgical Vision, Inc. |
09/02/2025 |
|
P990080
S064 |
30-Day Notice | TECNIS 3-Piece Acrylic Monofocal, Model ZA9003 |
Johnson & Johnson Surgical Vision, Inc. |
09/02/2025 |
|
P160017
S124 |
Panel Track | MiniMed 780G System | MEDTRONIC MINIMED, INC. | 08/29/2025 |
|
P010032
S242 |
30-Day Notice | Proclaim™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
Abbott Medical | 08/29/2025 |
|
P040043
S144 |
30-Day Notice | GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System (CMDS) 00733132646890; 00733132646906; 007331326 |
W. L. GORE & ASSOCIATES, INC. |
08/29/2025 |
|
P140009
S123 |
30-Day Notice | Infinity™ Deep Brain Stimulation (DBS) IPG |
Abbott Medical | 08/29/2025 |
|
P150004
S089 |
30-Day Notice | Proclaim™ Doral Root Ganglion (DRG) IPG |
Abbott Medical | 08/29/2025 |
|
P200030
S022 |
30-Day Notice | GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 00733132650927; 00733132650934; 00733132650941; 00733132650958; 00 |
W. L. Gore and Associates, Inc. |
08/29/2025 |
|
P230036
S014 |
30-Day Notice | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System |
Abbott Medical | 08/29/2025 |
|
P240013
S015 |
30-Day Notice | Sphere-9 Catheter Mapping And Ablation Catheter |
Medtronic Inc. | 08/29/2025 |
|
P830055
S348 |
30-Day Notice | LCS Total Knee System | DEPUY, INC. | 08/29/2025 |
|
P860004
S448 |
Special (Immediate Track) |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
MEDTRONIC Inc. | 08/29/2025 |
|
P080025
S328 |
30-Day Notice | InterStim™ Therapy System; Verify™ Evaluation System |
MEDTRONIC NEUROMODULATION |
08/28/2025 |
|
P160015
S020 |
Normal 180 Day Track No User Fee |
AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS |
ZOLL MEDICAL CORPORATION | 08/28/2025 |
|
P160022
S042 |
Normal 180 Day Track No User Fee |
AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS |
ZOLL MEDICAL CORPORATION | 08/28/2025 |
|
P180038
S027 |
30-Day Notice | LIAISON® Murex Anti-HBc And LIAISON® MUREX Control Anti-hbc |
DiaSorin Inc. | 08/28/2025 |
|
P180047
S040 |
30-Day Notice | LIAISON® QuantiFERON® - TB Gold Plus And LIAISON® Control QuantiFERON-TBGold Plus |
DiaSorin, Inc. | 08/28/2025 |
|
P190017
S028 |
30-Day Notice | LIAISON® XL MUREX HBsAg Qual And LIAISON® XL MUREX Control HBsAg Qual |
DiaSorin Inc | 08/28/2025 |
|
P200035
S028 |
Special (Immediate Track) |
OrganOx Metra® System | OrganOx Limited | 08/28/2025 |
|
P840001
S604 |
30-Day Notice | Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces-Quad™, Spe |
MEDTRONIC NEUROMODULATION |
08/28/2025 |
|
P860004
S447 |
30-Day Notice | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters |
MEDTRONIC Inc. | 08/28/2025 |
|
P960009
S516 |
30-Day Notice | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 08/28/2025 |
|
P970004
S433 |
30-Day Notice | InterStim™ Therapy System; Verify™ Evaluation System |
MEDTRONIC NEUROMODULATION |
08/28/2025 |
|
BP170122
1054 |
Normal 180 Day Track | ReCell Autologous Cell Harvesting Device |
Avita Medical | 08/28/2025 |
|
P130021
S174 |
Panel Track | Evolut PRO+ System, Evolut FX System, Evolut FX+ System |
Medtronic, Inc. | 08/27/2025 |
| P240044 | Original | Globe® Pulsed Field System | Kardium Inc. | 08/27/2025 |
|
P030054
S436 |
Real-Time Process | Quartet™ 1456Q, 1457Q, 1458Q, 1458QL; Avant™ HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Gallant™ HF CDHFA500B, CDHFA |
Abbott Medical | 08/27/2025 |
|
P040047
S078 |
Special (Immediate Track) |
COAPTITE Injectable Implant | MERZ NORTH AMERICA, INC | 08/27/2025 |
|
P160008
S028 |
Real-Time Process | HeartSine Technologies LLC's Samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P And SAM 450P) |
HeartSine Technologies, Ltd. |
08/27/2025 |
|
P160054
S110 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 08/27/2025 |
|
P910023
S479 |
Real-Time Process | Avant™ DR CDDRA700Q, CDDRA700T; Gallant™ DR CDDRA500Q, CDDRA500T; Entrant™ DR CDDRA300Q, CDDRA300T; Neutrino™ NxT DR CDD |
Abbott Medical | 08/27/2025 |
|
P950039
S041 |
30-Day Notice | ThinPrep Processor And ThinPrep Imaging System |
HOLOGIC, INC. | 08/27/2025 |
|
P960030
S081 |
Real-Time Process | IsoFlex™ (1944) | Abbott Medical | 08/27/2025 |
|
P160054
S111 |
30-Day Notice | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 08/26/2025 |
|
P230040
S018 |
30-Day Notice | CorPASS System | Endotronix, Inc. | 08/26/2025 |
|
P040020
S115 |
30-Day Notice | AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses\s |
Alcon Research, Ltd. | 08/25/2025 |
|
P040038
S049 |
30-Day Notice | XACT Carotid Stent System | ABBOTT VASCULAR INC. | 08/25/2025 |
|
P160007
S053 |
30-Day Notice | Guardian Connect System | MEDTRONIC MINIMED | 08/25/2025 |
|
P160017
S126 |
30-Day Notice | MiniMed 670G System | MEDTRONIC MINIMED, INC. | 08/25/2025 |
|
P160037
S022 |
Normal 180 Day Track No User Fee |
BD ONCLARITY HPV ASSAY | BECTON, DICKINSON AND COMPANY |
08/25/2025 |
|
P190018
S043 |
30-Day Notice | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens, |
Alcon Laboratories, LLC | 08/25/2025 |
|
P210032
S022 |
30-Day Notice | TAG® Thoracic Branch Endoprosthesis (P210032) |
W. L. Gore & Associates, Inc. |
08/25/2025 |
|
P220014
S008 |
Normal 180 Day Track | CraniSeal Dural Sealant | Pramand, LLC | 08/25/2025 |
|
P250012
S001 |
30-Day Notice | Simplera Sync Sensor, Guardian 4 Sensor |
Medtronic MiniMed Inc. | 08/25/2025 |
|
P930014
S157 |
30-Day Notice | AcrySof® Posterior Chamber Intraocular Lens And Delivery Systems |
ALCON LABORATORIES, INC. | 08/25/2025 |
|
P050023
S197 |
Real-Time Process | CardioMessenger Smart 4G | BIOTRONIK, INC. | 08/22/2025 |
|
P150012
S153 |
135 Review Track For 30-Day Notice |
INGEVITY™ MRI, INGEVITY™ + | BOSTONSCIENTIFIC | 08/22/2025 |
|
P200035
S026 |
Normal 180 Day Track | OrganOx Metra System | OrganOx Limited | 08/22/2025 |
|
P240009
S004 |
Special (Immediate Track) |
Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System With Integrated Embolic Protection |
Contego Medical Inc. | 08/22/2025 |
|
P910073
S176 |
135 Review Track For 30-Day Notice |
ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT™ |
BOSTON SCIENTIFIC | 08/22/2025 |
|
P960004
S106 |
135 Review Track For 30-Day Notice |
FINELINE® II EZ Sterox | BOSTON SCIENTIFIC | 08/22/2025 |
|
P990040
S036 |
30-Day Notice | TRUFILL N-bca Liquid Embolic System | Cerenovus, Inc. | 08/22/2025 |
|
P030039
S031 |
30-Day Notice | Coseal Spray Set | BAXTER BIO SCIENCE | 08/21/2025 |
|
P140017
S031 |
30-Day Notice | Melody Transcatheter Pumonary Valve System |
MEDTRONIC Inc. | 08/21/2025 |
|
P150033
S215 |
30-Day Notice | Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) |
MEDTRONIC Inc. | 08/21/2025 |
|
P150040
S021 |
30-Day Notice | Visumax; VISUMAX 800 | Carl Zeiss Meditec, Inc. | 08/21/2025 |
|
P170038
S026 |
30-Day Notice | CentriMag™ Circulatory Support System |
Abbott | 08/21/2025 |
|
P180038
S026 |
30-Day Notice | LIAISON® MUREX Anti-HBc And LIAISON® MUREX Control Anti-HBc |
DiaSorin Inc. | 08/21/2025 |
|
P180047
S038 |
30-Day Notice | LIAISON® QuantiFERON® - TB Gold Plus And LIAISON® XL Control QuantiFERON-TB Gold Plus |
DiaSorin, Inc. | 08/21/2025 |
|
P190002
S041 |
Real-Time Process | Saluda Medical Evoke SCS System | SALUDA MEDICAL PTY LTD | 08/21/2025 |
|
P190017
S027 |
30-Day Notice | LIAISON® MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg Qual And LIAISON® MUREX HBsAg Confirmatory |
DiaSorin Inc | 08/21/2025 |
|
P210032
S019 |
Normal 180 Day Track No User Fee |
GORE TAG Thoracic Branch Endoprosthesis (TBE Device) |
W. L. Gore & Associates, Inc. |
08/21/2025 |
|
P020004
S202 |
30-Day Notice | GORE® EXCLUDER® AAA Endoprosthesis | W.L. GORE & ASSOCIATES,INC |
08/20/2025 |
|
P080011
S184 |
Normal 180 Day Track No User Fee |
Up&up Monthly Performance + | CooperVision, Inc. | 08/20/2025 |
|
P080011
S186 |
Normal 180 Day Track No User Fee |
Iwear Oxygen Presbyopia | CooperVision, Inc. | 08/20/2025 |
|
P100009
S078 |
Special (Immediate Track) |
MitraClip G5 Delivery System | Abbott Medical | 08/20/2025 |
|
P100016
S022 |
30-Day Notice | CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P |
Carl Zeiss Meditec Production LLC |
08/20/2025 |
|
P120003
S010 |
30-Day Notice | Icast Covered Stent System | ATRIUM MEDICAL CORP. | 08/20/2025 |
|
P150033
S208 |
Real-Time Process | MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM |
MEDTRONIC Inc. | 08/20/2025 |
|
P160017
S122 |
Normal 180 Day Track No User Fee |
MiniMed 770G System | MEDTRONIC MINIMED, INC. | 08/20/2025 |
|
P170024
S024 |
30-Day Notice | Surpass Streamline Flow Diverter | Stryker Neurovascular | 08/20/2025 |
|
P200035
S025 |
Real-Time Process | OrganOx Metra® System | OrganOx Limited | 08/20/2025 |
|
P230007
S015 |
Special (Immediate Track) |
TriClip G5 Delivery System | Abbott Medical | 08/20/2025 |
|
P230022
S001 |
Normal 180 Day Track No User Fee |
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati |
Element Science, Inc. | 08/20/2025 |
|
P960058
S171 |
30-Day Notice | HiResolution™ Bionic Ear System | ADVANCED BIONICS | 08/20/2025 |
|
P170030
S055 |
Real-Time Process | Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System |
Biotronik, Inc | 08/19/2025 |
|
P960004
S108 |
30-Day Notice | THINLINE ENDOCARDIAL PACING LEADS | BOSTON SCIENTIFIC | 08/19/2025 |
|
P060037
S095 |
30-Day Notice | NexGen© LPSFlex/ LPS Mobile Bearing Knee System |
ZIMMER, INC. | 08/18/2025 |
|
P100009
S079 |
30-Day Notice | MitraClip Delivery System | Abbott Medical | 08/18/2025 |
|
P100026
S099 |
30-Day Notice | NeuroPace® RNS® System | NEUROPACE INC | 08/18/2025 |
|
P230007
S016 |
30-Day Notice | TriClip Delivery System | Abbott Medical | 08/18/2025 |
|
P980044
S064 |
30-Day Notice | SUPARTZ FX | SEIKAGAKU CORP. | 08/18/2025 |
|
P110019
S136 |
30-Day Notice | XIENCE Alpine™ Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra™ Everolimus Eluting Coronary Sten |
ABBOTT VASCULAR | 08/16/2025 |
| P250004 | Original | MMR IHC Panel Pharmdx (Dako Omnis) | Agilent Technologies, Inc. |
08/15/2025 |
| P250005 | Original | Idylla CDx MSI Test | Biocartis US, Inc. | 08/15/2025 |
|
P130022
S067 |
Normal 180 Day Track | Senza® HFX Iq™ System | Nevro Corporation | 08/15/2025 |
|
P150033
S212 |
Real-Time Process | Micra Transcatheter Pacing System (Micra AV/VR And Micra AV2/VR2) |
MEDTRONIC Inc. | 08/15/2025 |
|
P150035
S029 |
Normal 180 Day Track No User Fee |
AVEIR™ AR 2 LSP203A Leadless Pacemaker (LP) (atrial) |
Abbott Medical | 08/15/2025 |
|
P170008
S060 |
30-Day Notice | EluNIR™ Ridaforolimus Eluting Coronary Stent System |
Medinol, Ltd. | 08/15/2025 |
|
P240013
S013 |
Normal 180 Day Track No User Fee |
HexaGen™ RF Generator, HexaPulse™ PF Generator, HexaFlow™ Irrigation Pump |
Medtronic Inc. | 08/15/2025 |
|
P240031
S001 |
Normal 180 Day Track No User Fee |
Neuspera Sacral Neuromodulation System |
Neuspera Medical Inc | 08/15/2025 |
|
P000006
S071 |
Real-Time Process | Titan Inflatable Penile Prosthesis | COLOPLAST CORP. | 08/14/2025 |
|
P020025
S146 |
Normal 180 Day Track No User Fee |
Blazer™ II XP Cardiac Ablation Catheter And Cable |
BOSTON SCIENTIFIC | 08/14/2025 |
|
P050047
S105 |
30-Day Notice | Juvéderm Ultra XC, And Juvéderm Ultra Plus XC (hereafter Referred To As Ultra XC And Ultra Plus XC) |
Allergan | 08/14/2025 |
|
P060005
S022 |
30-Day Notice | IMMULITE 2000 Systems Free Prostate-Specific Antigen (Free PSA) |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED |
08/14/2025 |
|
P100018
S048 |
Normal 180 Day Track No User Fee |
Pipeline™ Vantage Embolization Device With Shield Technology™ |
Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR |
08/14/2025 |
|
P110033
S101 |
30-Day Notice | Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC And SKINVIVE By Juvéderm (hereafter Ref |
Allergan | 08/14/2025 |
|
P130021
S177 |
30-Day Notice | Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve; Medtronic Evolut™ PRO+ Transcatheter Aortic Valve; Medtroni |
Medtronic, Inc. | 08/14/2025 |
|
P150005
S089 |
Normal 180 Day Track No User Fee |
Blazer™ Open-Irrigated Ablation Catheter |
Boston Scientific Corp. | 08/14/2025 |
|
P190009
S009 |
Normal 180 Day Track No User Fee |
OPRA™ Implant System | Integrum AB | 08/14/2025 |
|
P220032
S011 |
Normal 180 Day Track No User Fee |
POLARx™ Cryoablation System | Boston Scientific Corporation |
08/14/2025 |
|
P230001
S010 |
30-Day Notice | ColoSense® | Geneoscopy, Inc. | 08/14/2025 |
|
P230030
S014 |
Normal 180 Day Track No User Fee |
FARAPULSE™ Pulsed Field Ablation System |
FARAPULSE, Inc. | 08/14/2025 |
|
P230040
S017 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 08/14/2025 |
|
P840001
S602 |
30-Day Notice | Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify™ |
MEDTRONIC NEUROMODULATION |
08/14/2025 |
|
P900056
S221 |
Normal 180 Day Track No User Fee |
ROTABLATOR™ Rotational Atherectomy System |
Boston Scientific Corp. | 08/14/2025 |
|
P920047
S137 |
Normal 180 Day Track No User Fee |
Blazer™ II Cardiac Ablation System And Cable |
Boston Scientific Corp. | 08/14/2025 |
|
P930027
S036 |
30-Day Notice | IMMULITE 2000 Prostate-Specific Antigen (PSA) |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
08/14/2025 |
|
P010030
S196 |
30-Day Notice | LifeVest® Wearable Defibrillator, Model 4000 |
ZOLL MANUFACTURING CORPORATION |
08/13/2025 |
|
P060001
S051 |
30-Day Notice | Protege™ RX Carotid Stent System | MEDTRONIC VASCULAR INC | 08/13/2025 |
|
P130029
S013 |
30-Day Notice | FLUENCY PLUS ENDOVASCULAR STENT GRAFT |
BARD PERIPHERAL VASCULAR, INC. |
08/13/2025 |
|
P210015
S007 |
Real-Time Process | Avive Automated External Defibrillator (AED) System |
Avive Solutions, Inc. | 08/13/2025 |
|
P230013
S016 |
Normal 180 Day Track No User Fee |
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement System |
Edwards Lifesciences LLC | 08/13/2025 |
|
P230042
S001 |
Real-Time Process | Optune Lua | Novocure GmbH | 08/12/2025 |
