| PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT (N970003/S256) | Boston Scientific Corp | 2020-10-01 |
| Venovo Venous Stent System (P180037/S004) | Bard Peripheral Vascular, Inc. | 2020-10-01 |
| PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI D (P150012/S101) | Boston Scientific | 2020-10-01 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD ORIGEN VR, ICD ORIGEN DR (P960040/S454) | Boston Scientific | 2020-10-01 |
| Supera Peripheral Stent System (P120020/S024) | Abbott Vascular (Idef Technologies Inc) | 2020-09-30 |
| 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 (P010031/S716) | Medtronic Cardiac Rhythm Disease Management | 2020-09-30 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S642) | Medtronic, Inc. | 2020-09-30 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S755) | Medtronic Cardiac Rhythm Disease Management | 2020-09-30 |
| THERMOCOOL SMARTTOUCH® SF Catheter (P030031/S100) | Biosense Webster, Inc. | 2020-09-30 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S450) | Medtronic, Inc. | 2020-09-30 |
| HeartWare Ventricular Assist System (P100047/S171) | Medtronic | 2020-09-30 |
| Brava CRT-D, Brava Quad CRT-D, Viva Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, and Viva XT CRT-D (P010031/S708) | Medtronic Cardiac Rhythm Disease Management | 2020-09-29 |
| Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR ICD, M (P980016/S748) | Medtronic Cardiac Rhythm Disease Management | 2020-09-29 |
| Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System (P900056/S188) | Boston Scientific Corp | 2020-09-29 |
| X Series, Propaq MD, and R Series (P160022/S022) | ZOLL Medical Corporation | 2020-09-29 |
| Micra TPS (P150033/S077) | Medtronic, Inc. | 2020-09-29 |
| Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System (P900056/S189) | Boston Scientific Corp | 2020-09-29 |
| X Series and Propaq MD (P160022/S020) | ZOLL Medical Corporation | 2020-09-29 |
| Tack Endovascular System (6F) (P180034/S003) | Philips Image Guided Therapy Corporation | 2020-09-28 |
| Tack Endovascular System (4F) (P190027/S001) | Philips Image Guided Therapy Corporation (Formerly Intact) | 2020-09-28 |
| Edwards Commander Delivery System (P140031/S119) | Edwards Lifesciences, LLC | 2020-09-25 |
| Rotablator Rotational Atherectomy System (P900056/S190) | Boston Scientific Corp | 2020-09-25 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S641) | Medtronic, Inc. | 2020-09-25 |
| Edwards Commander Delivery System (P200015/S004) | Edwards Lifesciences, LLC | 2020-09-25 |
| Covera Vascular Covered Stent (P170042/S007) | C.R. Bard, Inc. | 2020-09-25 |
| RF Conductr, RF Contactr, RF Marinr, and RF Enhancr II (P930029/S067) | Medtronic, Inc. | 2020-09-25 |
| FINELINE II Steroid-Eluting Pacing Leads (P960004/S091) | Boston Scientific | 2020-09-25 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S038) | Medtronic Vascular | 2020-09-25 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S104) | Medtronic Vascular | 2020-09-25 |
| LifeStent 5F Vascular Stent Systems (P070014/S061) | Bard Peripheral Vascular, Inc. | 2020-09-25 |
| Venovo Venous Stent System (P180037/S003) | Bard Peripheral Vascular, Inc. | 2020-09-25 |
| EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter (P990025/S060) | Biosense Webster, Inc. | 2020-09-24 |
| EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, EZ Steer Thermocool Bi-Directional Electrophysiology (P030031/S108) | Biosense Webster, Inc. | 2020-09-24 |
| EZ Steer NAV DS Bi-Directional Electrophysiology Catheter (P010068/S060) | Biosense Webster, Inc. | 2020-09-24 |
| EZ Steer DS Bi-Directional Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiology Catheter (P950005/S075) | Biosense Webster, Inc. | 2020-09-24 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S009) | Bard Peripheral Vascular, Inc. | 2020-09-24 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S004) | Medtronic Vascular, Inc. | 2020-09-24 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S449) | Medtronic, Inc. | 2020-09-23 |
| Avant VR ICD, Avant DR ICD, Neutrino NxT VR ICD, Neutrino NxT DR ICD, Gallant VR ICD, Gallant DR ICD, Entrant VR ICD and (P910023/S432) | ABBOTT MEDICAL | 2020-09-23 |
| Avant HF CRT-D, Neutrino NxT HF CRT-D, Gallant HF CRT-D, and Entrant HF CRT-D (P030054/S385) | ABBOTT MEDICAL | 2020-09-23 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S640) | Medtronic, Inc. | 2020-09-23 |
| Excor Pediatric Ventricular Assist Device (P160035/S013) | Berlin Heart, Inc. | 2020-09-23 |
| INCRAFT(R) AAA STENT GRAFT SYSTEM (P150002/S008) | Cordis US Corporation | 2020-09-23 |
| WOLVERINE Coronary Cutting Balloon (P950020/S109) | Boston Scientific Corp | 2020-09-22 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S034) | Medtronic Vascular | 2020-09-22 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/ II+ (P030054/S380) | ABBOTT MEDICAL | 2020-09-22 |
| Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S151) | Medtronic, Inc. | 2020-09-22 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+, Avant, Gallant, Entrant, Ne (P910023/S428) | ABBOTT MEDICAL | 2020-09-22 |
| AngioSculpt PTCA Scoring Balloon Catheter, AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S028) | Spectranetics Corp. | 2020-09-21 |
| VenaSeal Closure System (P140018/S020) | Medtronic Vascular, Inc. | 2020-09-21 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S754) | Medtronic Cardiac Rhythm Disease Management | 2020-09-18 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR (P980035/S639) | Medtronic, Inc. | 2020-09-18 |
| MANTA Vascular Closure Device (P180025/S008) | Teleflex Medical, LLC | 2020-09-18 |
| 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 (P010031/S715) | Medtronic Cardiac Rhythm Disease Management | 2020-09-18 |
| LifeVest Wearable Defibrillator (P010030/S142) | Zoll Manufacturing Corporation | 2020-09-17 |
| Carbomedics Prosthetic Heart Valve, Carbo-Seal Ascending Aortic Prosthesis, Carbo-Seal Valsalva Ascending Aortic Prosthe (P900060/S061) | Corcym S.r.l. | 2020-09-17 |
| Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S180) | Boston Scientific Corp | 2020-09-17 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) (P150003/S063) | Boston Scientific Corporation | 2020-09-17 |
| LATITUDE Programming System (Programmer) (P910077/S181) | Boston Scientific | 2020-09-17 |
| Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead (P050023/S149) | Biotronik, Inc. | 2020-09-17 |
| LOTUS Edge Valve System (P180029/S026) | Boston Scientific Corporation | 2020-09-17 |
| EMBLEM S-ICD Programmer (P110042/S144) | Boston Scientific Corporation | 2020-09-17 |
| AED 3 BLS (P160022/S021) | ZOLL Medical Corporation | 2020-09-17 |
| LIFEPAK CR2 Automated External Defibrillator (P170018/S008) | Physio-Control, Inc. | 2020-09-17 |
| GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (P020004/S176) | W. L. Gore & Associates, Inc. | 2020-09-16 |
| LIFEPAK Automated External Defibrillators (P160026/S020) | Physio-Control, Inc. | 2020-09-16 |
| Cobalt MRI CRT-P, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S714) | Medtronic Cardiac Rhythm Disease Management | 2020-09-15 |
| Avanta, Neutrino NXT, Gallant, Entrant VR ICD and Avant, Neutrino, Gallant and Entrant DR ICD (P910023/S429) | ABBOTT MEDICAL | 2020-09-15 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S448) | Medtronic, Inc. | 2020-09-15 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S753) | Medtronic Cardiac Rhythm Disease Management | 2020-09-15 |
| Avant HF, Neutrino NxT HF, Gallant HF and Entrant HF CRT-D (P030054/S381) | ABBOTT MEDICAL | 2020-09-15 |
| VICI VENOUS STENT System (P180013/S002) | Boston Scientific Corporation | 2020-09-15 |
| Omnilink Elite OTW Stent System (P110043/S012) | Abbott Vascular-Cardiac Therapies | 2020-09-11 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S005) | Medtronic Vascular, Inc. | 2020-09-11 |
| AngioSculpt PTCA Scoring Balloon Catheter, Rapid Exchange (RX) (P050018/S026) | Spectranetics Corp. | 2020-09-11 |
| Multi-Link Vision RX Coronary Stent System, Multi-Link Mini Vision RX Coronary Stent System, Multi-Link 8/8SV/8LL Corona (P020047/S073) | Abbott Vascular | 2020-09-11 |
| Subcutaneous Implantable Cardioverter Defibrillator (P110042/S145) | Boston Scientific Corporation | 2020-09-10 |
| Rotablator Rotational Atherectomy System (Rotablator, RotaLink Plus) and ROTAPRO Rotational Atherectomy System (ROTAPRO, (P900056/S187) | Boston Scientific Corp | 2020-09-10 |
| EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S112) | Edwards Lifesciences, LLC | 2020-09-09 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist. (P140003/S075) | Abiomed, Inc. | 2020-09-09 |
| Venovo Venous Stent System (P180037/S002) | Bard Peripheral Vascular, Inc. | 2020-09-09 |
| Ascendra+ Delivery System, NovaFlex+ Delivery System (P130009/S111) | Edwards Lifesciences, LLC | 2020-09-07 |
| Commander Delivery System, Certitude Delivery System (P140031/S118) | Edwards Lifesciences, LLC | 2020-09-07 |
| EDWARDS INTUITY Elite Delivery System (P150036/S052) | Edwards Lifesciences, LLC | 2020-09-07 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv (P150048/S048) | Edwards Lifesciences, LLC | 2020-09-07 |
| HeartWare Ventricular Assist System (P100047/S170) | Medtronic | 2020-09-04 |
| ESSENTIO, PROPONENT, ACCOLADE - MRI Pacemakers (P150012/S098) | Boston Scientific | 2020-09-03 |
| VICI VENOUS STENT System (P180013/S004) | Boston Scientific Corporation | 2020-09-03 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S015) | Berlin Heart, Inc. | 2020-09-03 |
| XACT Carotid Stent System (P040038/S036) | Abbott Vascular, Inc. | 2020-09-03 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 - Non MRI Pacemakers (N970003/S253) | Boston Scientific Corp | 2020-09-03 |
| VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 - Cardiac Resynchronization Therapy Pacemaker (CRT-P) (P030005/S199) | Guidant Corp. | 2020-09-03 |
| HeartWare HVAD System (P100047/S166) | Medtronic | 2020-09-03 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S036) | Boston Scientific Corp | 2020-09-02 |
| Innova Vascular Self-Expanding Stent System (P140028/S063) | Boston Scientific Corporation | 2020-09-02 |
| OPTIMIZER Smart System (P180036/S005) | Impulse Dynamics (Usa), Inc. | 2020-09-02 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S119) | W. L. Gore & Associates, Inc. | 2020-09-02 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015) | Edwards Lifesciences, LLC | 2020-08-31 |
| Innova Vascular Self-Expanding Stent System (P140028/S064) | Boston Scientific Corporation | 2020-08-28 |
| AngelMed Guardian System (P150009/S003) | Avertix Medical, Inc. | 2020-08-28 |