| PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
|---|---|---|---|---|
|
P030016
S046 |
30-Day Notice | Visian ICL (Implantable Collamer Lens), Visian Toric ICL (Implantable Collamer Lens), Visian EVO/EVO+ ICL (Implantable C |
STAAR Surgical Company | 05/10/2024 |
|
P040047
S074 |
30-Day Notice | Coaptite Injectable Implant | MERZ NORTH AMERICA, INC | 05/10/2024 |
|
P050037
S138 |
30-Day Notice | RADIESSE® Injectable Implant | MERZ NORTH AMERICA, INC | 05/10/2024 |
|
P050052
S160 |
30-Day Notice | RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline |
MERZ NORTH AMERICA, INC | 05/10/2024 |
|
P080025
S294 |
30-Day Notice | InterStim Therapy System, Verify Evaluation System |
MEDTRONIC NEUROMODULATION |
05/10/2024 |
|
P160047
S036 |
30-Day Notice | MARA Water Vapor Ablation System | CooperSurgical, Inc. | 05/10/2024 |
|
P180003
S009 |
Special (Immediate Track) |
BioMimics 3D® Vascular Stent | Veryan Medical Ltd. | 05/10/2024 |
|
P970004
S399 |
30-Day Notice | InterStim Therapy System, Verify Evaluation System |
MEDTRONIC NEUROMODULATION |
05/10/2024 |
|
P000009
S107 |
Real-Time Process | Acticor 7 DR-T, Rivacor 7 DR-T, Rivacor 5 DR-T, Rivacor 3 DR-T |
BIOTRONIK, INC. | 05/09/2024 |
|
P050023
S180 |
Real-Time Process | Acticor 7 HF-T, Rivacor 7 HF -T, Rivacor 5 HF -T, Rivacor 3 HF-T, Acticor 7 HF-T QP, Rivacor 7 HF –T QP, Rivacor 5 HF –T |
BIOTRONIK, INC. | 05/09/2024 |
|
P140031
S173 |
30-Day Notice | Edwards SAPIEN 3 Ultra Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valves |
EDWARDS LIFESCIENCES, LLC. |
05/09/2024 |
|
P230007
S001 |
30-Day Notice | TriClip™ G4 Clip Delivery System | Abbott Medical | 05/09/2024 |
|
P980023
S124 |
Real-Time Process | Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR, -T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T D |
BIOTRONIK, INC. | 05/09/2024 |
|
P050047
S094 |
30-Day Notice | Juvéderm Injectable Gel Implants (Ultra, Ultra XC, Ultra Plus XC) |
Allergan | 05/08/2024 |
|
P090016
S059 |
30-Day Notice | Belotero Balance Dermal Filler, Belotero Balance(+) Lidocaine Dermal Filler |
MERZ NORTH AMERICA, INC | 05/08/2024 |
|
P100021
S121 |
30-Day Notice | Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System, Endurant II AUI Stent Graf |
Medtronic Vascular | 05/08/2024 |
|
P100040
S063 |
30-Day Notice | Valiant Thoracic Stent Graft System (FreeFlo Tapers Line Extention) With Captivia Delivery System, Valiant Thoracic Sten |
Medtronic Vascular | 05/08/2024 |
|
P110033
S083 |
30-Day Notice | Juvéderm Injectable Gel Implants (Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive) |
Allergan | 05/08/2024 |
|
P130021
S163 |
30-Day Notice | CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Sys |
Medtronic, Inc. | 05/08/2024 |
|
P140010
S080 |
30-Day Notice | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter And IN.PACT 018 Paclitax |
MEDTRONIC Inc. | 05/08/2024 |
|
P140018
S042 |
30-Day Notice | VenaSeal Closure System | MEDTRONIC VASCULAR INC | 05/08/2024 |
|
P150033
S188 |
30-Day Notice | Micra TPS, Micra VR TPS, Micra AV TPS |
MEDTRONIC Inc. | 05/08/2024 |
|
P160043
S081 |
30-Day Notice | Resolute Onyx Rapid Exchange Zotarolimus Eluting Coronary Stent System, Resolute Onyx Frontier Rapid Exchange Zotarolim |
MEDTRONIC VASCULAR | 05/08/2024 |
|
P170025
S021 |
30-Day Notice | Aptima HBV Quant Assay | Hologic, Inc | 05/08/2024 |
|
P170030
S033 |
135 Review Track For 30-Day Notice |
ORSIRO Sirolimus Eluting Coronary Stent System |
Biotronik, Inc | 05/08/2024 |
|
P190008
S029 |
30-Day Notice | IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter |
Medtronic Vascular Inc. | 05/08/2024 |
|
P190019
S030 |
30-Day Notice | Ranger Paclitaxel-Coated PTA Balloon Catheter |
Boston Scientific Corporation |
05/08/2024 |
|
P200046
S033 |
30-Day Notice | Harmony Delivery Catheter System | Medtronic, Inc. | 05/08/2024 |
|
P210036
S001 |
135 Review Track For 30-Day Notice |
PerClot® Polysaccharide Hemostatic System |
Baxter Healthcare Corporation |
05/08/2024 |
|
P220026
S007 |
30-Day Notice | Symplicity Spyral' Multi-Electrode Renal Denervation Catheter |
Medtronic Inc. | 05/08/2024 |
|
P970051
S220 |
Normal 180 Day Track No User Fee |
Nucleus 24 Cochlear Implant System | Cochlear Americas | 05/08/2024 |
|
P010015
S537 |
30-Day Notice | Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
MEDTRONIC Inc. | 05/07/2024 |
|
P130021
S162 |
30-Day Notice | Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medt |
Medtronic, Inc. | 05/07/2024 |
|
P980035
S780 |
30-Day Notice | Advisa DR IPG, Advisa DR MRl IPG, Advisa SR MRl IPG, Astra S DR MRl IPG, Astra S SR MRl IPG, Astra XT DR MRl IPG, Astra |
MEDTRONIC Inc. | 05/07/2024 |
|
P010030
S176 |
30-Day Notice | LifeVest Wearable Defibrillator Model 5100 |
ZOLL MANUFACTURING CORPORATION |
05/03/2024 |
|
P110023
S046 |
30-Day Notice | EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent With Entrust™ Delivery Syste |
MEDTRONIC VASCULAR INC | 05/03/2024 |
|
P190015
S018 |
Real-Time Process | TREO® Abdominal Stent-Graft System | Bolton Medical Inc. | 05/03/2024 |
| P230001 | Original | Colosense® | Geneoscopy, Inc. | 05/03/2024 |
|
P230030
S004 |
30-Day Notice | FARAPULSE Pulsed Field Ablation System |
FARAPULSE, Inc. | 05/03/2024 |
|
N16837
S033 |
30-Day Notice | Artegraft Collagen Vascular Graft | LeMaitre Vascular, Inc. | 05/02/2024 |
|
P010032
S210 |
Real-Time Process | Eterna™ SCS IPG | Abbott Medical | 05/02/2024 |
|
P050037
S136 |
30-Day Notice | RADIESSE® Injectable Implant | MERZ NORTH AMERICA, INC | 05/02/2024 |
|
P050052
S158 |
30-Day Notice | RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline |
MERZ NORTH AMERICA, INC | 05/02/2024 |
|
P110023
S045 |
30-Day Notice | EverFlex™ Self-Expanding Peripheral Stent System, 2 EverFlex™ Self-Expanding Peripheral Stent With Entrust™ Delivery Sys |
MEDTRONIC VASCULAR INC | 05/02/2024 |
|
P110033
S079 |
Normal 180 Day Track No User Fee |
JUVÉDERM® VOLUMA ® XC | Allergan | 05/02/2024 |
|
P130005
S042 |
Normal 180 Day Track No User Fee |
DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (OAS) |
CARDIOVASCULAR SYSTEMS, INC. |
05/02/2024 |
|
P140009
S092 |
Real-Time Process | Liberta RC™ DBS IPG | Abbott Medical | 05/02/2024 |
|
P160054
S078 |
30-Day Notice | HeartMate 3 Left Ventricular Assist System |
Abbott Medical | 05/02/2024 |
|
P180046
S083 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Axonics Modulation Technologies, Inc. |
05/02/2024 |
|
P190006
S083 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Axonics Modulation Technologies, Inc. |
05/02/2024 |
|
P220012
S024 |
30-Day Notice | Epsila EV Extravascular Lead | Medtronic, Inc. | 05/02/2024 |
|
P950037
S256 |
30-Day Notice | Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4 |
BIOTRONIK, INC. | 05/02/2024 |
|
P990004
S066 |
30-Day Notice | SURGIFLO Hemostatic Matrix, SURGIFLO Hemostatic Matrix Kit With Thrombin |
Ferrosan Meidcal Devices A/S |
05/02/2024 |
|
N12159
S109 |
30-Day Notice | SURGICEL® Absorbable Hemostats | ETHICON, INC. | 05/01/2024 |
|
P030035
S201 |
30-Day Notice | Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP Family Of CRT-Ps |
Abbott Medical | 05/01/2024 |
|
P030054
S419 |
30-Day Notice | Avant, Gallant, Entrant, Neutrino NxT Family Of CRT-Ds |
Abbott Medical | 05/01/2024 |
|
P090029
S020 |
30-Day Notice | Prestige LP (R) Cervical Disc | Medtronic Sofamor Danek USA, Inc. |
05/01/2024 |
|
P140033
S088 |
30-Day Notice | Assurity MRI, Endurity MRI, Zenus MRI And Zenex MRI Family Of Pacemakers |
Abbott Medical | 05/01/2024 |
|
P150035
S010 |
30-Day Notice | Aveir VR Delivery Catheter And Aveir DR Delivery Catheter |
Abbott Medical | 05/01/2024 |
|
P160042
S023 |
Real-Time Process | Revanesse Lips+ With Lidocaine 1.2 Ml |
PROLLENIUM MEDICAL TECHNOLOGIES INC. |
05/01/2024 |
|
P170038
S016 |
30-Day Notice | CentriMag Circulatory Support System | Abbott | 05/01/2024 |
|
P190002
S025 |
Real-Time Process | Saluda Medical Evoke® SCS System; Implantable Pulse Generator (Model 3042) |
SALUDA MEDICAL PTY LTD | 05/01/2024 |
|
P190034
S005 |
Normal 180 Day Track | Elecsys Anti-HBs II, PreciControl Anti-HBs |
Roche Diagnostics | 05/01/2024 |
|
P230017
S002 |
Real-Time Process | PulseSelect™ Pulsed Field Ablation (PFA) System |
Medtronic, Inc. | 05/01/2024 |
|
P880086
S336 |
30-Day Notice | Assurity, Assurity+, Endurity, Endurity Core, Zenus, Zenex Family Of Pacemakers |
Abbott Medical | 05/01/2024 |
|
P910023
S464 |
30-Day Notice | Avant, Gallant, Entrant, Neutrino NxT Family Of ICDs |
Abbott Medical | 05/01/2024 |
|
N970003
S291 |
Real-Time Process | ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I |
Boston Scientific Corp. | 04/30/2024 |
|
P010012
S580 |
Real-Time Process | COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA |
Boston Scientific Corp. | 04/30/2024 |
|
P010032
S214 |
30-Day Notice | Eterna SCS IPG | Abbott Medical | 04/30/2024 |
|
P030005
S236 |
Real-Time Process | INVIVE, INTUA, VISIONIST, VALITUDE | GUIDANT CORP. | 04/30/2024 |
|
P110042
S193 |
Real-Time Process | EMBLEM S-ICD | BOSTON SCIENTIFIC CORPORATION |
04/30/2024 |
|
P140009
S096 |
30-Day Notice | Liberta RC DBS IPG | Abbott Medical | 04/30/2024 |
|
P150012
S155 |
Real-Time Process | INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI |
BOSTONSCIENTIFIC | 04/30/2024 |
|
P170034
S012 |
135 Review Track For 30-Day Notice |
Hydrus® Microstent | Ivantis, Inc. wholly-owned subsidiary of Alcon Research, LLC |
04/30/2024 |
|
P910077
S193 |
Real-Time Process | LATITUDE™ Programming System | BOSTON SCIENTIFIC | 04/30/2024 |
|
P960040
S499 |
Real-Time Process | TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA |
BOSTON SCIENTIFIC | 04/30/2024 |
|
P020018
S063 |
30-Day Notice | Zenith Fenestrated AAA Endovascular Graft |
COOK, INC. | 04/29/2024 |
|
P030017
S371 |
Real-Time Process | WaveWriter Alpha SCS System | Boston Scientific Corp. | 04/29/2024 |
|
P030050
S050 |
30-Day Notice | SCULPTRA (injectable Poly-l Lactic Acid) |
Q-Med AB | 04/29/2024 |
|
P050006
S109 |
Real-Time Process | GORE® CARDIOFORM ASD Occluder, GORE® CARDIOFORM Septal Occluder |
W.L. GORE & ASSOCIATES,INC |
04/29/2024 |
|
P100047
S215 |
Real-Time Process | HeartWare™ HVAD System | Medtronic | 04/29/2024 |
|
P140016
S011 |
30-Day Notice | Zenith Alpha Thoracic Endovascular Graft |
COOK MEDICAL INCORPORATED |
04/29/2024 |
|
P150030
S036 |
Normal 180 Day Track No User Fee |
R3 Delta Ceramic Hip System | Smith & Nephew, Inc. | 04/29/2024 |
|
P160026
S047 |
30-Day Notice | LIFEPAK® 35 Monitor/Defibrillator | Physio-Control. Inc. | 04/29/2024 |
|
P160026
S048 |
30-Day Notice | LIFEPAK® 35 Monitor/Defibrillator | Physio-Control. Inc. | 04/29/2024 |
|
P180001
S012 |
30-Day Notice | Zenith Dissection Endovascular System |
WILLIAM COOK EUROPE APS | 04/29/2024 |
| P230036 | Original | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System |
Abbott Medical | 04/26/2024 |
|
P010031
S856 |
Normal 180 Day Track No User Fee |
CareLink SmartSync Cobalt, Crome App, Cobalt XT MRI CRT-D |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
04/26/2024 |
|
P020012
S047 |
30-Day Notice | Bellafill Dermal Filler | SUNEVA MEDICAL, INC. | 04/26/2024 |
|
P120016
S036 |
30-Day Notice | Vascular Closure System (VCS) | CARDIVA MEDICAL, INC. | 04/26/2024 |
|
P840001
S563 |
30-Day Notice | Intellis, Sequentia LT, And Vanta Spinal Cord Stimulation Systems |
MEDTRONIC NEUROMODULATION |
04/26/2024 |
|
P890003
S466 |
Normal 180 Day Track No User Fee |
Heart Failure Risk Status (HFRS), Triage-HF |
Medtronic, Inc. | 04/26/2024 |
|
P960009
S477 |
30-Day Notice | Activa Deep Brain Stimulation Therapy System, Percept PC And RC BrainSense |
MEDTRONIC Inc. | 04/26/2024 |
|
P980016
S890 |
Normal 180 Day Track No User Fee |
Cobalt XT MRI ICD | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
04/26/2024 |
|
P010015
S536 |
30-Day Notice | Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
MEDTRONIC Inc. | 04/25/2024 |
|
P010031
S855 |
30-Day Notice | Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
04/25/2024 |
|
P100018
S044 |
Real-Time Process | Pipeline™ Flex Embolization Device With Shield Technology™ (PED2), Pipeline™ Vantage Embolization Device With Shield Tec |
Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR |
04/25/2024 |
|
P150033
S186 |
30-Day Notice | Medtronic Micra Transcatheter Pacemaker System |
MEDTRONIC Inc. | 04/25/2024 |
|
P170019
S045 |
Normal 180 Day Track | FoundationOne CDx | Foundation Medicine, Inc. |
04/25/2024 |
|
P170027
S013 |
30-Day Notice | TherOx Downstream System | ZOLL Circulation, Inc. | 04/25/2024 |
|
P220012
S021 |
30-Day Notice | Aurora EV-ICD | Medtronic, Inc. | 04/25/2024 |
|
P980016
S889 |
30-Day Notice | Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera X |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
04/25/2024 |
|
P080025
S293 |
30-Day Notice | InterStim Therapy System, Verify Evaluation System |
MEDTRONIC NEUROMODULATION |
04/24/2024 |
|
P130008
S109 |
30-Day Notice | Model 4063 Stimulation Lead And 4340 Sensing Lead |
INSPIRE MEDICAL SYSTEMS | 04/24/2024 |
|
P130013
S068 |
30-Day Notice | WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device With Delivery System And WATCHMAN FLX Pro Left Atrial Appendage |
Boston Scientific Corp. | 04/24/2024 |
|
P160003
S020 |
30-Day Notice | PRO-Kinetic Energy Coronary Stent System |
BIOTRONIK, INC. | 04/24/2024 |
|
P170030
S037 |
30-Day Notice | Orsiro Mission Sirolimus Eluting Coronary Stent System |
Biotronik, Inc | 04/24/2024 |
|
P170038
S015 |
30-Day Notice | CentriMag™ Circulatory Support System |
Abbott | 04/24/2024 |
|
P220012
S020 |
Normal 180 Day Track No User Fee |
Aurora EV-ICD System | Medtronic, Inc. | 04/24/2024 |
|
P230013
S003 |
30-Day Notice | EVOQUE Tricuspid Valve Replacement System |
Edwards Lifesciences LLC | 04/24/2024 |
|
P840001
S512 |
Normal 180 Day Track | Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int |
MEDTRONIC NEUROMODULATION |
04/24/2024 |
|
P840001
S561 |
30-Day Notice | SCS Neurostimulators Implantable Itrel Family |
MEDTRONIC NEUROMODULATION |
04/24/2024 |
|
P840001
S562 |
30-Day Notice | Restore, Itrel, Synergy, Intellis And Vanta Spinal Cord Stimulation Systems And Pisces, Specify, And Vectris Spinal Cord |
MEDTRONIC NEUROMODULATION |
04/24/2024 |
|
P860004
S425 |
30-Day Notice | SynchroMed Infusion System, Ascenda Intrathecal Catheters |
MEDTRONIC Inc. | 04/24/2024 |
|
P960009
S475 |
30-Day Notice | DBS Neurostimulators Implantable Activa Family |
MEDTRONIC Inc. | 04/24/2024 |
|
P960009
S476 |
30-Day Notice | Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
MEDTRONIC Inc. | 04/24/2024 |
|
P970004
S398 |
30-Day Notice | InterStim Therapy System, Verify Evaluation System |
MEDTRONIC NEUROMODULATION |
04/24/2024 |
|
P170018
S019 |
30-Day Notice | LIFEPAK® CR2 Defibrillator | Physio-Control, Inc | 04/23/2024 |
|
P190008
S028 |
Normal 180 Day Track No User Fee |
IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon |
Medtronic Vascular Inc. | 04/23/2024 |
|
P170006
S033 |
30-Day Notice | Avalus Bioprosthesis And Avalus Ultra Bioprosthesis |
Medtronic Inc. | 04/22/2024 |
|
P170006
S034 |
30-Day Notice | Avalus Bioprosthesis, Avalus Ultra Bioprosthesis |
Medtronic Inc. | 04/22/2024 |
|
P170038
S014 |
30-Day Notice | CentriMag™ Circulatory Support System |
Abbott | 04/22/2024 |
|
P180038
S017 |
Normal 180 Day Track | LIAISON Murex Anti-HBc And LIAISON Murex Control Anti-HBc |
DiaSorin Inc. | 04/22/2024 |
|
P790007
S066 |
30-Day Notice | Hancock Modified Orifice Valved Conduit |
MEDTRONIC HEART VALVES | 04/22/2024 |
|
P870078
S051 |
30-Day Notice | Hancock Valved Conduit | Medtronic, Inc. | 04/22/2024 |
|
P970031
S073 |
30-Day Notice | Freestyle Bioprosthesis | Medtronic, Inc. | 04/22/2024 |
|
P980043
S079 |
30-Day Notice | Hancock II Bioprosthesis | Medtronic, Inc. | 04/22/2024 |
|
P990064
S088 |
30-Day Notice | Mosaic Bioprosthesis | Medtronic, Inc. | 04/22/2024 |
|
P000009
S109 |
30-Day Notice | Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T |
BIOTRONIK, INC. | 04/19/2024 |
|
P050023
S182 |
30-Day Notice | Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T, In |
BIOTRONIK, INC. | 04/19/2024 |
|
P130012
S016 |
30-Day Notice | Myopore® Sutureless Myocardial Pacing Lead |
Greatbatch Medical | 04/19/2024 |
|
P130021
S161 |
30-Day Notice | Medtronic Evolut FX+ Transcatheter Aortic Valve, Evolut FX Delivery Catheter System, Evolut FX Loading System |
Medtronic, Inc. | 04/19/2024 |
|
P160017
S116 |
Real-Time Process | Medtronic MiniMed 780G Insulin Pump (MMT-1884), Medtronic MiniMed 780G Insulin Pump Kit (MMT-1894) |
MEDTRONIC MINIMED, INC. | 04/19/2024 |
|
P180050
S011 |
Special (Immediate Track) |
BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si |
CVRx, INC. | 04/19/2024 |
|
P220025
S003 |
30-Day Notice | LimFlow System | LimFlow, Inc. | 04/19/2024 |
|
P980023
S125 |
30-Day Notice | Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- |
BIOTRONIK, INC. | 04/19/2024 |
|
P200011
S001 |
Panel Track | Oncorevealtm CDx | Pillar Biosciences | 04/18/2024 |
|
P030050
S041 |
Real-Time Process | Sculptra, Sculptra Aesthetic | Q-Med AB | 04/18/2024 |
|
P050006
S110 |
30-Day Notice | GORE® CARDIOFORM ASD Occluder | W.L. GORE & ASSOCIATES,INC |
04/18/2024 |
|
P130013
S067 |
30-Day Notice | WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device With Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl |
Boston Scientific Corp. | 04/18/2024 |
|
P160035
S039 |
Normal 180 Day Track | Berlin Heart EXCOR Pediatric Ventricular Assist Device |
Berlin Heart Inc. | 04/18/2024 |
|
P160037
S019 |
Real-Time Process | BD Onclarity™ HPV Assay | BECTON, DICKINSON AND COMPANY |
04/18/2024 |
| P230014 | Original | Lumicell Direct Visualization System (DVS) |
Lumicell, Inc. | 04/17/2024 |
|
P040045
S136 |
30-Day Notice | VISTAKON (senofilcon A) Brand Contact Lenses |
VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR |
04/17/2024 |
|
P110038
S031 |
30-Day Notice | RelayPlus Thoracic Stent-Graft System |
BOLTON MEDICAL, INC. | 04/17/2024 |
|
P170011
S053 |
Special (Immediate Track) |
Impella RP And Impella RP With SmartAssist |
Abiomed, Inc. | 04/17/2024 |
|
P190015
S017 |
30-Day Notice | TREO Abdominal Stent-Graft System | Bolton Medical Inc. | 04/17/2024 |
|
P200022
S013 |
Normal 180 Day Track No User Fee |
Simplify® Cervical Artificial Disc | NuVasive, Inc. | 04/17/2024 |
|
P200045
S011 |
30-Day Notice | RelayPro Stent-Graft System | Bolton Medical, Inc. | 04/17/2024 |
|
P220007
S004 |
30-Day Notice | Precision7 ™, Precision7 ™ For Astigmatism, Precision7 ™ Multifocal, Precision7 ™ Multifocal Toric |
Alcon Laboratories, Inc. | 04/17/2024 |
|
P030004
S031 |
30-Day Notice | Apollo™ Onyx™ Delivery Micro Catheter 1.5 Cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 Cm |
EV3 NEUROVASCULAR | 04/16/2024 |
|
P060040
S103 |
30-Day Notice | HeartMate II Left Ventricular Assist System |
Abbott Medical | 04/16/2024 |
|
P080006
S183 |
30-Day Notice | Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
MEDTRONIC Inc. | 04/16/2024 |
|
P130008
S108 |
30-Day Notice | Model 2740 Inspire Physician Programmer |
INSPIRE MEDICAL SYSTEMS | 04/16/2024 |
|
P130013
S065 |
Normal 180 Day Track No User Fee |
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device With Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl |
Boston Scientific Corp. | 04/16/2024 |
|
P150033
S187 |
30-Day Notice | Micra AV TPS, Micra TPS | MEDTRONIC Inc. | 04/16/2024 |
|
P160054
S077 |
30-Day Notice | HeartMate 3 Left Ventricular Assist System |
Abbott Medical | 04/16/2024 |
|
P190032
S020 |
30-Day Notice | FoundationOne®Liquid CDx (F1LCDx) | Foundation Medicine Inc. | 04/16/2024 |
|
P220012
S022 |
30-Day Notice | Epsila EV Extravascular Lead | Medtronic, Inc. | 04/16/2024 |
|
P830061
S222 |
30-Day Notice | CapSure Sense Lead, Vitatron Crystalline Lead |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
04/16/2024 |
|
P920015
S285 |
135 Review Track For 30-Day Notice |
Y Adaptor/Extender Kit, Sprint Quattro Lead |
MEDTRONIC Inc. | 04/16/2024 |
|
P920015
S286 |
30-Day Notice | HV Splitter, Sprint Quattro Lead | MEDTRONIC Inc. | 04/16/2024 |
|
P930039
S259 |
30-Day Notice | CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
Medtronic, Inc. | 04/16/2024 |
|
P040029
S022 |
30-Day Notice | Euclid Orthokeratology (oprifocon A) Contact Lenses For Overnight Wear And Euclid Orthokeratology (tisilfocon A) Contact |
Euclid Vision Corporation |
04/15/2024 |
|
P110007
S014 |
Normal 180 Day Track | Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate) |
Johnson & Johnson Surgical Vision, Inc. |
04/15/2024 |
|
P160053
S009 |
Normal 180 Day Track | Magtrace And Sentimag Magnetic Localization System |
ENDOMAGNETICS LTD. | 04/15/2024 |
|
P220003
S015 |
Normal 180 Day Track | PASCAL Precision Transcatheter Valve Repair System |
Edwards LifeSciences LLC | 04/15/2024 |
|
P810031
S075 |
Normal 180 Day Track | Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack |
Johnson & Johnson Surgical Vision, Inc. |
04/15/2024 |
|
P040044
S101 |
30-Day Notice | MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F) |
Cordis US Corporation | 04/12/2024 |
|
P160026
S040 |
Normal 180 Day Track | LIFEPAK® 35 Monitor/Defibrillator | Physio-Control. Inc. | 04/12/2024 |
|
P180036
S027 |
Normal 180 Day Track No User Fee |
OPTIMIZER Smart System | Impulse Dynamics (USA), Inc. |
04/12/2024 |
|
P180046
S081 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Axonics Modulation Technologies, Inc. |
04/12/2024 |
|
P190006
S081 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Axonics Modulation Technologies, Inc. |
04/12/2024 |
|
P110020
S042 |
30-Day Notice | Roche Cobas 4800 BRAF V600 Mutation Test |
Roche Molecular Systems, Inc. |
04/11/2024 |
|
P130022
S057 |
30-Day Notice | Senza® Spinal Cord Stimulation (SCS) System |
Nevro Corporation | 04/11/2024 |
|
P140023
S029 |
30-Day Notice | Roche Cobas DNA Sample Preparation Kit |
Roche Molecular Systems, Inc. |
04/11/2024 |
|
P160043
S079 |
30-Day Notice | Resolute Onyx Zotarolimus-Eluting Coronary Stent System-RX And OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent Sys |
MEDTRONIC VASCULAR | 04/11/2024 |
|
P180032
S016 |
Special (Immediate Track) |
Cerene Cryotherapy Device (Model Number FGS-7000) |
Channel Medsystems, Inc. | 04/11/2024 |
|
P200040
S001 |
Normal 180 Day Track No User Fee |
SoftVue™ Automated Whole Breast Ultrasound System With Sequr™ Breast Interface |
Delphinus Medical Technologies |
04/11/2024 |
|
P230035
S001 |
Normal 180 Day Track No User Fee |
AGENT Paclitaxel-Coated Balloon Catheter |
Boston Scientific Corporation |
04/11/2024 |
|
P960009
S472 |
Real-Time Process | Percept™ RC BrainSense™ | MEDTRONIC Inc. | 04/11/2024 |
|
P100021
S120 |
30-Day Notice | Medtronic CoreValve™ Evolut PRO System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs |
Medtronic Vascular | 04/10/2024 |
|
P100040
S062 |
30-Day Notice | Valiant Thoracic Stent Graft With The Captivia Delivery System |
Medtronic Vascular | 04/10/2024 |
|
P130021
S160 |
30-Day Notice | Medtronic CoreValve™ Evolut R System |
Medtronic, Inc. | 04/10/2024 |
|
P130022
S053 |
135 Review Track For 30-Day Notice |
Senza Spinal Cord Stimulation (SCS) System |
Nevro Corporation | 04/10/2024 |
|
P160043
S080 |
30-Day Notice | Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX And OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent S |
MEDTRONIC VASCULAR | 04/10/2024 |
|
P170008
S048 |
Normal 180 Day Track | EluNIR-PERL Ridaforolimus Eluting Coronary Stent System |
Medinol, Ltd. | 04/10/2024 |
|
P180046
S082 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Axonics Modulation Technologies, Inc. |
04/10/2024 |
|
P190006
S082 |
30-Day Notice | Axonics Sacral Neuromodulation System |
Axonics Modulation Technologies, Inc. |
04/10/2024 |
|
P220012
S019 |
30-Day Notice | Aurora EV-ICD System | Medtronic, Inc. | 04/10/2024 |
|
P220026
S006 |
30-Day Notice | Symplicity Spyral™ Renal Denervation System |
Medtronic Inc. | 04/10/2024 |
|
P890003
S465 |
Real-Time Process | CareLink SmartSync | Medtronic, Inc. | 04/10/2024 |
|
P100009
S064 |
30-Day Notice | MitraClip™ NTR/XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System |
Abbott Medical | 04/09/2024 |
|
P190009
S005 |
Real-Time Process | OPRA Implant System | Integrum AB | 04/09/2024 |
|
P840001
S559 |
Real-Time Process | Master Restore, Itrel®, Synergy®, IntellisTM And VantaTM Spinal Cord Stimulation Systems And PiscesTM, Specify®, And Vec |
MEDTRONIC NEUROMODULATION |
04/09/2024 |
|
P860004
S424 |
Real-Time Process | SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
MEDTRONIC Inc. | 04/09/2024 |
|
P900060
S066 |
30-Day Notice | Carbomedics Prosthetic Heart Valve | CORCYM S.r.l. | 04/09/2024 |
|
P960009
S470 |
Real-Time Process | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 04/09/2024 |
|
BP120001
S714 |
Normal 180 Day Track | OraQuick® In-Home HIV Test | OraSure Technologies, Inc |
04/09/2024 |
|
P030036
S146 |
30-Day Notice | SelectSecure Lead | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
04/08/2024 |
