| Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR (P910023/S440) | ABBOTT MEDICAL | 2021-09-01 |
| LifeVest Wearable Defibrillator (P010030/S150) | Zoll Manufacturing Corporation | 2021-09-01 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Zotarolimus-Eluting Coronary Stent System (2.0mm) (P160043/S054) | Medtronic Vascular | 2021-08-31 |
| EDWARDS INTUITY Elite Aortic Valve (P150036/S055) | Edwards Lifesciences, LLC | 2021-08-31 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve and Accessories (P140031/S133) | Edwards Lifesciences, LLC | 2021-08-31 |
| INOUE-BALLOON Catheter (P910054/S008) | Toray Industries (America), Inc. | 2021-08-31 |
| SAPIEN 3 Transcatheter Heart Valve and Accesssories (P200015/S012) | Edwards Lifesciences, LLC | 2021-08-31 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System, Resolute Integrity Zotarolimus-Eluting Coronary Stent Syst (P110013/S114) | Medtronic Vascular | 2021-08-31 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (FLX) (P130013/S045) | Boston Scientific Corp | 2021-08-25 |
| Impella 5.5 with SmartAssist (P140003/S087) | Abiomed, Inc. | 2021-08-23 |
| Freezor Xtra Cardiac Cryoablation Catheter (P020045/S099) | Medtronic Cryocath, LP | 2021-08-22 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S032) | Medinol, Ltd. | 2021-08-20 |
| SelectSecure Lead (P030036/S132) | Medtronic Cardiac Rhythm Disease Management | 2021-08-20 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S198) | Medtronic Cardiac Rhythm Disease Management | 2021-08-20 |
| CapSure SP Novus Lead, CapSure Z Novus Lead (P850089/S157) | Medtronic Cardiac Rhythm Disease Management | 2021-08-20 |
| CentriMag Circulatory Support System (P170038/S007) | Abbott | 2021-08-19 |
| 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- (P980023/S107) | Biotronik, Inc. | 2021-08-19 |
| Masters Mechanical Heart Valve (P810002/S113) | ABBOTT MEDICAL | 2021-08-19 |
| Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T (P070008/S128) | Biotronik, Inc. | 2021-08-19 |
| Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T ( (P950037/S227) | Biotronik, Inc. | 2021-08-19 |
| Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T ( (P050023/S160) | Biotronik, Inc. | 2021-08-19 |
| Sprint Quattro Lead (P920015/S257) | Medtronic, Inc. | 2021-08-19 |
| Sprint Quattro Lead, Y Adaptor/Extender (P920015/S258) | Medtronic, Inc. | 2021-08-19 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S094) | Biotronik, Inc. | 2021-08-19 |
| CapSure Epicardial Pacing Lead (P950024/S099) | Medtronic, Inc. | 2021-08-17 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S156) | Medtronic Cardiac Rhythm Disease Management | 2021-08-17 |
| End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S165) | Medtronic Cardiac Rhythm Disease Management | 2021-08-17 |
| Myocardial Pacing Lead (P120017/S028) | Medtronic, Inc. | 2021-08-17 |
| CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S197) | Medtronic Cardiac Rhythm Disease Management | 2021-08-17 |
| IntellaTip MiFi Filter Module, IntellaTip MiFi Reference Cable, EGM Cable, Maestro 4000 Footswitch (P020025/S132) | Boston Scientific | 2021-08-17 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S162) | Medtronic, Inc. | 2021-08-17 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S447) | Medtronic, Inc. | 2021-08-17 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, (P980016/S789) | Medtronic Cardiac Rhythm Disease Management | 2021-08-17 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad (P920015/S259) | Medtronic, Inc. | 2021-08-17 |
| 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 M (P010031/S754) | Medtronic Cardiac Rhythm Disease Management | 2021-08-17 |
| Adapta, Versa, Sensia IPG (P980035/S689) | Medtronic, Inc. | 2021-08-17 |
| Transvene CS/SVC Lead (P980050/S134) | Medtronic, Inc. | 2021-08-17 |
| Attain StarFix Lead (P060039/S108) | Medtronic, Inc. | 2021-08-17 |
| Tridyne Vascular Sealant (P150016/S019) | Neomend, Inc. | 2021-08-17 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead (P010015/S481) | Medtronic, Inc. | 2021-08-17 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S131) | Medtronic Cardiac Rhythm Disease Management | 2021-08-17 |
| CapSureFix Lead (P930039/S229) | Medtronic, Inc. | 2021-08-17 |
| CareLink SmartSync Azure Astra Application (P980035/S684) | Medtronic, Inc. | 2021-08-16 |
| PROMUS Premier and PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S197) | Boston Scientific Corp | 2021-08-16 |
| CareLink SmartSync Percepta Serena Solara Application (P010015/S475) | Medtronic, Inc. | 2021-08-16 |
| CareLink SmartSync Cobalt, Crome Application (P010031/S747) | Medtronic Cardiac Rhythm Disease Management | 2021-08-16 |
| CareLink SmartSync Platform, CareLink SmartSync Common Application and CareLink SmartSync MRI Host Application (P890003/S445) | Medtronic, Inc. | 2021-08-16 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049) | ABBOTT MEDICAL | 2021-08-14 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S183) | W. L. Gore & Associates, Inc. | 2021-08-13 |
| GORE CARDIOFORM Septal Occluder (P050006/S094) | W. L. Gore & Associates, Inc. | 2021-08-13 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S145) | W. L. Gore & Associates, Inc. | 2021-08-13 |
| X Series, AED Pro, Propaq MD (P160022/S030) | ZOLL Medical Corporation | 2021-08-13 |
| AED 3, AED Plus (P160015/S012) | ZOLL Medical Corporation | 2021-08-13 |
| Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot (P060027/S105) | MicroPort CRM USA, Inc. | 2021-08-13 |
| Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot (P950029/S129) | MicroPort CRM USA, Inc. | 2021-08-13 |
| Assurity MRI, Endurity MRI (P140033/S068) | ABBOTT MEDICAL | 2021-08-13 |
| Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot (P980049/S141) | MicroPort CRM USA, Inc. | 2021-08-13 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S084) | W. L. Gore & Associates, Inc. | 2021-08-13 |
| CardioMessenger Smart 4G (P050023/S159) | Biotronik, Inc. | 2021-08-13 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S051) | Medtronic Vascular | 2021-08-13 |
| Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI I (P980035/S688) | Medtronic, Inc. | 2021-08-12 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera XT DR ICD, Ev (P980016/S788) | Medtronic Cardiac Rhythm Disease Management | 2021-08-12 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S131) | Edwards Lifesciences, LLC | 2021-08-12 |
| AngioJet Thrombectomy System (P980037/S086) | Boston Scientific Corp | 2021-08-12 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S480) | Medtronic, Inc. | 2021-08-12 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S479) | Medtronic, Inc. | 2021-08-12 |
| Medtronic Evolut FX System (P130021/S094) | Medtronic, Inc. | 2021-08-12 |
| HeartWare HVAD System (P100047/S174) | Medtronic | 2021-08-12 |
| 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 MR (P010031/S753) | Medtronic Cardiac Rhythm Disease Management | 2021-08-12 |
| AngioJet Thrombectomy System (P980037/S085) | Boston Scientific Corp | 2021-08-11 |
| CardioMEMS HF System (P100045/S053) | ABBOTT MEDICAL | 2021-08-10 |
| HeartWare HVAD System (P100047/S188) | Medtronic | 2021-08-10 |
| HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HS1 SMART Pads, Adult, HS1 SMART Pads, Infant/Child (P160029/S013) | Philips Medical Systems, Inc. | 2021-08-10 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System (P130021/S097) | Medtronic, Inc. | 2021-08-10 |
| CardioMEMS HF System (P100045/S054) | ABBOTT MEDICAL | 2021-08-10 |
| Durata, Optisure (P950022/S141) | ABBOTT MEDICAL | 2021-08-09 |
| Tendril STS, Tendril ST, Optisense (P960013/S120) | ABBOTT MEDICAL | 2021-08-09 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S052) | Medtronic Vascular | 2021-08-09 |
| Blazer Open Irrigated Ablation Catheter (P150005/S066) | Boston Scientific Corp | 2021-08-06 |
| Arctic Front Advance Pro Cardiac Cryoablation Catheter, 23mm, US and Arctic Front Advance Pro Cardiac Cryoablation Cathe (P100010/S116) | Medtronic Cryocath, LP | 2021-08-06 |
| Lutonix 018 Drug Coated Balloon PTA Catheters (P170003/S019) | Lutonix | 2021-08-06 |
| Lutonix 035 Drug Coated Balloon PTA Catheters (P130024/S038) | Lutonix | 2021-08-06 |
| VASCADE MVP VVCS (P120016/S028) | Cardiva Medical, Inc. | 2021-08-06 |
| LifeStent Vascular Stent Systems (P070014/S063) | Bard Peripheral Vascular, Inc. | 2021-08-05 |
| Bard Fluency Plus Endovascular Stent Graft (P130029/S010) | Bard Peripheral Vascular, Inc. | 2021-08-05 |
| Venovo Venous Stent System (P180037/S006) | Bard Peripheral Vascular, Inc. | 2021-08-05 |
| Lutonix 035 Drug Coated Balloon Catheter, Lutonix 018 Drug Coated Balloon Catheter (P130024/S041) | Lutonix | 2021-08-05 |
| CentriMag Circulatory Support System (P170038/S006) | Abbott | 2021-08-05 |
| RelayPro Thoracic Stent-Graft System (P200045) | Bolton Medical, Inc. | 2021-08-05 |
| IntellaNav ST Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II HTD Temperature Ablation Catheter, a (P920047/S124) | Boston Scientific Corp | 2021-08-05 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System, Endurant II AUI Stent Graf (P100021/S094) | Medtronic Vascular | 2021-08-05 |
| Lutonix 018 Drug Coated Balloon Catheter (P170003/S023) | Lutonix | 2021-08-05 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S048) | Medtronic Vascular | 2021-08-05 |
| Blazer II XP Temperature Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, IntellaTip MiFi XP Temperatur (P020025/S129) | Boston Scientific | 2021-08-05 |
| Bard E-Luminexx and LifeStar Vascular Stent (P080007/S025) | Bard Peripheral Vascular, Inc. | 2021-08-05 |
| Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaNav MiFi Open-Irrigated Abl (P150005/S061) | Boston Scientific Corp | 2021-08-05 |
| Covera Vascular Covered Stent (P170042/S010) | C.R. Bard, Inc. | 2021-08-05 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S043) | Boston Scientific Corp | 2021-08-04 |
| Melody Transcatheter Pulmonary Valve (P140017/S019) | Medtronic, Inc. | 2021-08-03 |
| TactiCath Quartz Contact Force Ablation Catheter (P130026/S069) | St Jude Medical | 2021-08-03 |