| Eluvia Drug-Eluting Vascular Stent System (P180011/S013) | Boston Scientific Corp | 2019-10-11 |
| Edwards INSPIRIS RESILIA Aortic Valve (P150048/S038) | Edwards Lifesciences, LLC | 2019-10-10 |
| EMBLEM S-ICD Electrode (P110042/S128) | Boston Scientific Corporation | 2019-10-10 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (P130005/S027) | Cardiovascular Systems, Inc. | 2019-10-09 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S051) | St Jude Medical | 2019-10-09 |
| FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled (P110016/S064) | ABBOTT MEDICAL | 2019-10-09 |
| Freezor Cardiac Cryoablation System (P020045/S090) | Medtronic Cryocath, LP | 2019-10-09 |
| ENDOLOGIX POWERLINK SYSTEM (P040002/S062) | Endologix, LLC | 2019-10-08 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S170) | W. L. Gore & Associates, Inc. | 2019-10-08 |
| Wallstent Venous RP & Endoprosthesis with Unistep Plus (P980033/S056) | Boston Scientific Corporation | 2019-10-07 |
| LOTUS Edge Valve System (P180029/S013) | Boston Scientific Corporation | 2019-10-07 |
| Epic Vascular Self Expanding Stent System (P110035/S053) | Boston Scientific Corp | 2019-10-07 |
| SLS/GlideLight (P960042/S067) | Spectranetics (Philips) | 2019-10-07 |
| Wallstent RP Endoprosthesis Iliac (P940019/S057) | Boston Scientific Scimed, Inc. | 2019-10-07 |
| Wallstent Endoprostheis TIPS with Unistep Plus (P930031/S066) | Boston Scientific Corp | 2019-10-07 |
| HeartWare Ventricular Assist System (P100047/S147) | Medtronic | 2019-10-07 |
| Innova Vascular Self Expanding Stent System (P140028/S046) | Boston Scientific Corporation | 2019-10-07 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S016) | Boston Scientific Corp | 2019-10-07 |
| IntellaTip MiFi Open Irrigated (P150005/S048) | Boston Scientific Corp | 2019-10-07 |
| Corox OTW BP (P070008/S107) | Biotronik, Inc. | 2019-10-04 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008/S106) | Biotronik, Inc. | 2019-10-04 |
| TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (P050023/S134) | Biotronik, Inc. | 2019-10-04 |
| 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, Compia M (P010031/S680) | Medtronic Cardiac Rhythm Disease Management | 2019-10-04 |
| Evera MRI DF1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR (P980016/S719) | Medtronic Cardiac Rhythm Disease Management | 2019-10-04 |
| LUTONIX® 035 Drug Coated Balloon PTA Catheter (P170003/S007) | Lutonix | 2019-10-04 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S204) | Biotronik, Inc. | 2019-10-04 |
| PHYLAX AV ICD SYSTEM (P000009/S081) | Biotronik, Inc. | 2019-10-04 |
| PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980023/S094) | Biotronik, Inc. | 2019-10-04 |
| MynxGrip, Mynx Ace, and Mynx Control Vascular Closure Device (VCD) (P040044/S085) | Cordis US Corporation | 2019-10-03 |
| LOTUS Edge Valve System (P180029/S014) | Boston Scientific Corporation | 2019-10-03 |
| Edwards SAPIEN 3 Transcatheter Heart Valves and Edwards SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S096) | Edwards Lifesciences, LLC | 2019-10-03 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.0/LD Systems (P140003/S058) | Abiomed, Inc. | 2019-10-03 |
| Impella RP System (P170011/S016) | Abiomed, Inc. | 2019-10-03 |
| GORE TAG Thoracic Endoprosthesis (P040043/S110) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| LUTONIX 035 Drug Coated Balloon PTA Catheter (P170003/S012) | Lutonix | 2019-10-02 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S020) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S069) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S164) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S072) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| GORE CARDIOFORM Septal Occulder (P050006/S075) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S130) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| GORE TIGRIS Vascular Stent (P160004/S027) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| Azure and Astra MRI SureScan IPG and Pacing System (P980035/S601) | Medtronic, Inc. | 2019-10-01 |
| TriageHF (P890003/S418) | Medtronic, Inc. | 2019-10-01 |
| Edwards Sapien 3 Ultra Delivery System and Edwards Commander Delivery System (P140031/S095) | Edwards Lifesciences, LLC | 2019-09-30 |
| AngioJet Ultra Thrombectomy System (P980037/S076) | Boston Scientific Corp | 2019-09-30 |
| MitraClip G4 Clip Delivery System (P100009/S036) | ABBOTT MEDICAL | 2019-09-30 |
| Amplia, Claria MRI CRT-D, Amplia, Claria and Compia MRI Quad CRT-D, Brava Quad CRT-D, Brava, Consulta and Protecta CRT-D (P010031/S681) | Medtronic Cardiac Rhythm Disease Management | 2019-09-27 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad (P920015/S236) | Medtronic, Inc. | 2019-09-27 |
| Evera/Visia AF MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR (P980016/S720) | Medtronic Cardiac Rhythm Disease Management | 2019-09-27 |
| CapSure Sense Leand and CapSure SP Novus Lead (P830061/S175) | Medtronic Cardiac Rhythm Disease Management | 2019-09-27 |
| CapSure Epicardial Pacing Lead (P950024/S088) | Medtronic, Inc. | 2019-09-27 |
| CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit and Vitatron Brilliant S+ VDD Lead (P890003/S419) | Medtronic, Inc. | 2019-09-27 |
| Micra TPS (P150033/S056) | Medtronic, Inc. | 2019-09-27 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead (P850089/S144) | Medtronic Cardiac Rhythm Disease Management | 2019-09-27 |
| Ace Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve (P900061/S155) | Medtronic Cardiac Rhythm Disease Management | 2019-09-27 |
| Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S140) | Medtronic, Inc. | 2019-09-27 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Attesta D (P980035/S605) | Medtronic, Inc. | 2019-09-27 |
| Attain OTW LV Lead, Consulta CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara B (P010015/S419) | Medtronic, Inc. | 2019-09-27 |
| Myocardial Pacing Lead (P120017/S019) | Medtronic, Inc. | 2019-09-27 |
| Attain StarFix Lead (P060039/S096) | Medtronic, Inc. | 2019-09-27 |
| LOTUS Edge Valve System (P180029/S012) | Boston Scientific Corporation | 2019-09-26 |
| EXCLUDER AAA Endoprosthesis (P020004/S168) | W. L. Gore & Associates, Inc. | 2019-09-26 |
| Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, and Resonate Cardiac Resynchronization Therapy Defibrillator (CRT- (P010012/S509) | Boston Scientific Corp | 2019-09-24 |
| Valitude, Valitude X4, Visionist, and Visionist X4 Cardiac Resynchronization Therapy - Pacemaker (CRT-P) (P030005/S189) | Guidant Corp. | 2019-09-24 |
| Essentio, Proponent, and Accolade MRI Pacemakers (P150012/S082) | Boston Scientific | 2019-09-24 |
| Carpentier-Edwards PERIMOUNT/PERIMOUNT RSR/Magna Pericardial Aortic Bioprosthesis; Carpentir-Edwards PERIMOUNT Theon/PER (P860057/S191) | Edwards Lifesciences, LLC | 2019-09-24 |
| Edwards Intuity Elite Valve System (P150036/S041) | Edwards Lifesciences, LLC | 2019-09-24 |
| Impella 5.5 with SmartAssist (P140003/S050) | Abiomed, Inc. | 2019-09-24 |
| sentus QP LV Lead (P070008/S104) | Biotronik, Inc. | 2019-09-24 |
| Origen, Inogen, Dynagen, Autogen, Vigilant, Resonate, Perciva, and Momentum Implantable Cardioverter Defibrillator (ICD) (P960040/S442) | Boston Scientific | 2019-09-24 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S099) | Edwards Lifesciences, LLC | 2019-09-24 |
| EP Passion Initiative (P050023/S132) | Biotronik, Inc. | 2019-09-24 |
| Impella 2.5, Impella CP, Impella CP with SmatAssist, Impella 5.0/LD Systems (P140003/S056) | Abiomed, Inc. | 2019-09-24 |
| Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S092) | Edwards Lifesciences, LLC | 2019-09-24 |
| Impella RP System (P170011/S014) | Abiomed, Inc. | 2019-09-24 |
| Essentio, Proponent, Accolade, and Altrua 2 Non-MRI Pacemakers (N970003/S243) | Boston Scientific Corp | 2019-09-24 |
| Edwards Pericardial Aortic/Mitral Bioprosthesis and Edwards Inspiris Resilia Aortic Valve (P150048/S037) | Edwards Lifesciences, LLC | 2019-09-24 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S015) | Boston Scientific Corp | 2019-09-23 |
| Innova Vascular Self-Expanding Stent System (P140028/S045) | Boston Scientific Corporation | 2019-09-23 |
| SelectSecure MRI SureScan Lead (P030036/S113) | Medtronic Cardiac Rhythm Disease Management | 2019-09-20 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S021) | Medinol, Ltd. | 2019-09-20 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S014) | Celonova Biosciences, Inc. | 2019-09-20 |
| Evolut PRO+ Sysstem (P130021/S059) | Medtronic, Inc. | 2019-09-19 |
| Beta-Cath System (P000018/S050) | Best Vascular, Inc. | 2019-09-19 |
| SynCardia temporary Total Artificial Heart (Tah-t) System (P030011/S072) | Syncardia Systems, LLC | 2019-09-19 |
| LifeVest Wearable Defibrillator (P010030/S121) | Zoll Manufacturing Corporation | 2019-09-19 |
| LifeVest Wearable Defibrillator (P010030/S122) | Zoll Manufacturing Corporation | 2019-09-19 |
| Diamondback 360 Coronary Orbital Atherectomy System (P130005/S021) | Cardiovascular Systems, Inc. | 2019-09-19 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S096) | Medtronic Cryocath, LP | 2019-09-19 |
| Micra Transcatheter Pacemaker System (P150033/S058) | Medtronic, Inc. | 2019-09-19 |
| Autogen, Dynagen, Inogen, and Origen NG3 CRT-Ds and Resonate, Momentum, and Vigilant NG4 CRT-Ds (P010012/S506) | Boston Scientific Corp | 2019-09-18 |
| Autogen, Dynagen, Inogen, and Origen NG3 ICDs and Resonate, Momentum, Vigilant, and Perciva NG4 ICDs (P960040/S440) | Boston Scientific | 2019-09-18 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S007) | Berlin Heart, Inc. | 2019-09-18 |
| Valitude and Visionist Non-MRI CRT-Ps and Valitude X4 and Visionist X4 MRI CRT-Ps (P030005/S186) | Guidant Corp. | 2019-09-18 |
| Micra Transcatheter Pacing System (P150033/S057) | Medtronic, Inc. | 2019-09-18 |
| Essentio, Proponent, and Accolade MRI Pacemakers (P150012/S080) | Boston Scientific | 2019-09-18 |
| Vascade MVP VVCS (P120016/S027) | Cardiva Medical, Inc. | 2019-09-18 |
| TactiCath Quartz Contact Force Ablation Catheter (P130026/S050) | St Jude Medical | 2019-09-18 |
| Altrua 2, Essentio, Proponent, and Accolade Non-MRI Pacemakers (N970003/S241) | Boston Scientific Corp | 2019-09-18 |