| PROMUS Element Plus, PREMIER and ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S163) | Boston Scientific Corp | 2020-01-03 |
| HeartMate 3 Left Ventricular Assist System (P160054/S024) | ABBOTT MEDICAL | 2019-12-30 |
| Cobra PzF NanoCoated Coronary Stent System (P160014/S009) | Celonova Biosciences, Inc. | 2019-12-24 |
| Assurity, Assurity+, Endurity, Accent family of Pacemaker (P880086/S307) | ABBOTT MEDICAL | 2019-12-23 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S177) | ABBOTT MEDICAL | 2019-12-23 |
| Microny family of Pacemakers (P970013/S081) | ABBOTT MEDICAL | 2019-12-23 |
| Assurity MRI and Endurity MRI family of Pacemakers (P140033/S049) | ABBOTT MEDICAL | 2019-12-23 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S373) | ABBOTT MEDICAL | 2019-12-23 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S422) | ABBOTT MEDICAL | 2019-12-23 |
| VenaSeal Closure System (P140018/S017) | Medtronic Vascular, Inc. | 2019-12-20 |
| Quadripolar Pacing (P030054/S372) | ABBOTT MEDICAL | 2019-12-20 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S010) | Berlin Heart, Inc. | 2019-12-20 |
| Gore Excluder AAA Endoprosthesis and Gore Excluder Iliac Branch Endoprosthesis (P020004/S172) | W. L. Gore & Associates, Inc. | 2019-12-20 |
| BioGlue Surgical Adhesive (P010003/S037) | Cryolife, Inc. | 2019-12-20 |
| Siello/Solia S Leads Tip (P950037/S208) | Biotronik, Inc. | 2019-12-20 |
| CP Stent, Covered CP Stent, Mounted CP Stent, Covered and Mounted CP Stent, Mounted CP Stent, NuDEL (P150028/S004) | NuMED, Inc. | 2019-12-19 |
| Innova Vascular Self-Expanding Stent with Delivery System (P140028/S051) | Boston Scientific Corporation | 2019-12-19 |
| MyCareLink Smart Patient Reader, CareLink Encore Programmer (P890003/S424) | Medtronic, Inc. | 2019-12-19 |
| LifeVest Wearable Defibrillator (P010030/S130) | Zoll Manufacturing Corporation | 2019-12-19 |
| Emblem Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S131) | Boston Scientific Corporation | 2019-12-19 |
| Epic Vascular Self-Expanding Stent System (P110035/S054) | Boston Scientific Corp | 2019-12-19 |
| Implantav Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, Dual-Chamber and Defibrillator, automatic im (P050023/S140) | Biotronik, Inc. | 2019-12-19 |
| AngioJet Rheolythic Thrombectomy Catheter (P980037/S077) | Boston Scientific Corp | 2019-12-19 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB) (P130024/S030) | Lutonix | 2019-12-19 |
| Lutonix 018 Drug Coated Balloon PTA Catheters (P130024/S032) | Lutonix | 2019-12-18 |
| Innova Vascular Self-Expanding Stent System (P140028/S050) | Boston Scientific Corporation | 2019-12-18 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S097) | Medtronic Vascular | 2019-12-18 |
| Astra S DR/SR MRI IPG, Astra XT DR/DR MRI IPG and Azure S SR MRI IPG XT DR/SR MRI IPG (P980035/S610) | Medtronic, Inc. | 2019-12-18 |
| Rebel Platinum Chromium Coronary Stent System (Monrail and Over-The-Wire) (P130030/S064) | Boston Scientific Corp | 2019-12-18 |
| CareLink SmartSync Device Manager Programmer (P890003/S423) | Medtronic, Inc. | 2019-12-18 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S076) | W. L. Gore & Associates, Inc. | 2019-12-18 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S020) | Boston Scientific Corp | 2019-12-18 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P and Solara Bipolar/Qu (P010015/S423) | Medtronic, Inc. | 2019-12-18 |
| LUTONIX® 035 Drug Coated Balloon PTA Catheter (P170003/S015) | Lutonix | 2019-12-18 |
| EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems of the Evolut R, PRO, PRO+ Systems (P130021/S070) | Medtronic, Inc. | 2019-12-17 |
| Tendril ST and Tendril STS Low Voltage Leads (P960013/S110) | ABBOTT MEDICAL | 2019-12-17 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S029) | Medtronic Vascular | 2019-12-17 |
| CardioMessenger Smart 4G LTE (P050023/S138) | Biotronik, Inc. | 2019-12-17 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S048) | Medtronic, Inc. | 2019-12-17 |
| LOTUS Edge Valve System (P180029/S018) | Boston Scientific Corporation | 2019-12-17 |
| EMBLEM S-ICD Automated Screening Tool (P110042/S129) | Boston Scientific Corporation | 2019-12-16 |
| Brava CRT-D, Brava Quad CRT-D, Viva Quad CRT-D, Viva Quad S/XT CRT-D, and Viva S/XT CRT-D (P010031/S683) | Medtronic Cardiac Rhythm Disease Management | 2019-12-16 |
| Evera S DR/VR ICd, Evera XT DR/VR ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR/VR ICD, and Primo MRI DR/VR ICD (P980016/S722) | Medtronic Cardiac Rhythm Disease Management | 2019-12-16 |
| Multiple Application Utility (MAU) and Data Management System (DM) LATITUDE Programming System )LPS) (P910077/S174) | Boston Scientific | 2019-12-16 |
| X Series®/Propaq MD device (P160022/S008) | ZOLL Medical Corporation | 2019-12-16 |
| Perceval Sutureless Heart Valve (P150011/S017) | Corcym S.r.l. | 2019-12-16 |
| INGEVITY (P150012/S085) | Boston Scientific | 2019-12-16 |
| Ingevity + Lead - Active Fixation (P150012/S083) | Boston Scientific | 2019-12-16 |
| TactiCath Quartz Contact Force Ablation Catheter (TactiCath Quartz) (P130026/S054) | St Jude Medical | 2019-12-16 |
| MULTI-LINK ULTRA RX Coronary Stent System (P970020/S084) | Abbott Vascular, Inc. | 2019-12-13 |
| CapSure Epicardial Pacing Lead (P950024/S089) | Medtronic, Inc. | 2019-12-13 |
| Attain Ability Lead (P080006/S142) | Medtronic, Inc. | 2019-12-13 |
| Attain StarFix Lead (P060039/S097) | Medtronic, Inc. | 2019-12-13 |
| Sprint Quattro Lead; Subcutaneous Lead; Transvene CS/SVC Lead (P920015/S238) | Medtronic, Inc. | 2019-12-13 |
| SelectSure Lead (P030036/S114) | Medtronic Cardiac Rhythm Disease Management | 2019-12-13 |
| CapSure Sense Lead; Vitatron Crystalline Lead (P830061/S176) | Medtronic Cardiac Rhythm Disease Management | 2019-12-13 |
| Transvene CS-SVC Lead (P980050/S123) | Medtronic, Inc. | 2019-12-13 |
| CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead (P930039/S206) | Medtronic, Inc. | 2019-12-13 |
| CapSure VDD-2 Lead; Vitatron Brilliant S+ VDD Lead (P890003/S421) | Medtronic, Inc. | 2019-12-13 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S021) | Boston Scientific Corp | 2019-12-13 |
| Innova Vascular Self-Expanding Stent System (P140028/S052) | Boston Scientific Corporation | 2019-12-13 |
| Angio-Seal Vascular Closure Devices (P930038/S097) | Terumo Medical Corporation | 2019-12-13 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S034) | Boston Scientific Corp | 2019-12-12 |
| Lotus Edge Valve System (P180029/S019) | Boston Scientific Corporation | 2019-12-11 |
| Micra TPS (P150033/S062) | Medtronic, Inc. | 2019-12-10 |
| Hancock II Bioprosthesis (P980043/S072) | Medtronic, Inc. | 2019-12-10 |
| Advisa DR, Advisa DR MRI, Advisa SR MRI, Astra S DR MRI, Astra S SR MRI, Asrtra XT DR MRI, Astra XT SR MRI, Azure S DR (P980035/S608) | Medtronic, Inc. | 2019-12-10 |
| Arctic Front Advance and Arctic Front Advance Pro (P100010/S099) | Medtronic Cryocath, LP | 2019-12-10 |
| EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems of the Evolut R/PRO/PRO+ Systems (P130021/S069) | Medtronic, Inc. | 2019-12-10 |
| Avalus (P170006/S016) | Medtronic, Inc. | 2019-12-10 |
| Hancock Valved Conduit Modified Orifice (P790007/S062) | Medtronic Heart Valves | 2019-12-10 |
| Evolut R and Evolut PRO (P130021/S064) | Medtronic, Inc. | 2019-12-10 |
| Melody (P140017/S016) | Medtronic, Inc. | 2019-12-10 |
| Freestyle Bioprosthesis (P970031/S067) | Medtronic, Inc. | 2019-12-10 |
| Attain Ability Leads, Attain Performa Leads, Attains Stability Quad MRI Lead (P080006/S144) | Medtronic, Inc. | 2019-12-10 |
| Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Mirro MRI DR, Mirro MRI VR, Primo MRI DR, P (P980016/S723) | Medtronic Cardiac Rhythm Disease Management | 2019-12-10 |
| Hancock Valved Conduit Low Porosity (P870078/S047) | Medtronic, Inc. | 2019-12-10 |
| Mosaic Bioprosthesis (P990064/S080) | Medtronic, Inc. | 2019-12-10 |
| Amplia MRI, Amplia MRI Quad, Brava, Brava Quad, Claria MRI, Claria MRI Quad, Compia MRI, Compia MRI Quad, Consulta, Prot (P010031/S684) | Medtronic Cardiac Rhythm Disease Management | 2019-12-10 |
| Consulta, Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, Solara Quadripolar (P010015/S421) | Medtronic, Inc. | 2019-12-10 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S129) | Zoll Manufacturing Corporation | 2019-12-09 |
| Gore Excluder AAA Endoprosthesis (P020004/S167) | W. L. Gore & Associates, Inc. | 2019-12-09 |
| LUTONIX® 035 Drug Coated Balloon PTA Catheter (P170003/S011) | Lutonix | 2019-12-09 |
| Lotus Edge Valve System (P180029/S003) | Boston Scientific Corporation | 2019-12-06 |
| CentriMag Circulatory Support System (P170038) | Abbott | 2019-12-06 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Conrolled Expansion (P040027/S075) | W. L. Gore & Associates, Inc. | 2019-12-06 |
| Assurity MRI and Endurity MRI Pacemakers (P140033/S051) | ABBOTT MEDICAL | 2019-12-06 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S012) | Celonova Biosciences, Inc. | 2019-12-06 |
| Endurity, Endurity Core, Assurity and Assurity + (P880086/S309) | ABBOTT MEDICAL | 2019-12-06 |
| ACUITY X4 Electrode 2, 3, and (E24) (P010012/S512) | Boston Scientific Corp | 2019-12-06 |
| LifeVest Wearable Defibrillator (P010030/S127) | Zoll Manufacturing Corporation | 2019-12-05 |
| Misago RX Self-expanding Peripheral Stent (P140002/S020) | Terumo Medical Corporation | 2019-12-05 |
| Innova Vascular Self-Expanding Stent System (P140028/S049) | Boston Scientific Corporation | 2019-12-04 |
| Innova Self-Expanding Stent System (P140028/S047) | Boston Scientific Corporation | 2019-12-04 |
| Origen Mini ICD VR, Origen Mini ICD DR, Inogen Mini ICD VR, Inogen Mini ICD DR, Dynagen Mini ICD VR, Dynagen Mini ICD DR (P960040/S445) | Boston Scientific | 2019-12-04 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S017) | Boston Scientific Corp | 2019-12-04 |
| Platinium 4LV CRT-D (P060027/S100) | MicroPort CRM USA, Inc. | 2019-12-04 |
| Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG and Azure S DR/SR MRI IPG, Azure XT DR/SR MRI IPG (P980035/S607) | Medtronic, Inc. | 2019-12-04 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S018) | Boston Scientific Corp | 2019-12-04 |
| Essentio SR, Essentio DR, Essentio EL DR, Proponent SR, Proponent DR, Proponent EL DR, Accolade SR, Accolade DR, Accola (N970003/S246) | Boston Scientific Corp | 2019-12-04 |