| Epic Vascular Self-Expanding Stent System (P110035/S060) | Boston Scientific Corp | 2020-07-30 |
| Micra AV TPS (P150033/S078) | Medtronic, Inc. | 2020-07-30 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S034) | Boston Scientific Corp | 2020-07-30 |
| Innova Vascular Self-Expanding Stent with Delivery System (P140028/S061) | Boston Scientific Corporation | 2020-07-30 |
| Consulta, Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, Solara Quadripolar (P010015/S442) | Medtronic, Inc. | 2020-07-29 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S632) | Medtronic, Inc. | 2020-07-29 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S017) | Physio-Control, Inc. | 2020-07-29 |
| CardioMEMS HF System (P100045/S044) | ABBOTT MEDICAL | 2020-07-28 |
| LIFEPAKAutomated External Defibrillators (AEDs) (P160026/S016) | Physio-Control, Inc. | 2020-07-28 |
| MyCareLink Network, Micra AV family of pacemakers (P890003/S430) | Medtronic, Inc. | 2020-07-24 |
| Adapta Versa Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, En (P980035/S628) | Medtronic, Inc. | 2020-07-24 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M (P980016/S742) | Medtronic Cardiac Rhythm Disease Management | 2020-07-24 |
| 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/S703) | Medtronic Cardiac Rhythm Disease Management | 2020-07-24 |
| Micra AV TPS, Micra TPS (P150033/S075) | Medtronic, Inc. | 2020-07-24 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S438) | Medtronic, Inc. | 2020-07-24 |
| AFX Endovascular AAA System (P040002/S065) | Endologix, LLC | 2020-07-23 |
| Endurant, Endurant II, and Endurant IIs Stent Graft System (P100021/S081) | Medtronic Vascular | 2020-07-23 |
| Valiant Thoracic Stent Graft with Captiva Delivery System (P100040/S040) | Medtronic Vascular | 2020-07-23 |
| RF Conductr, RF Contactr, RF Marinr, RF Enhancr II (P930029/S066) | Medtronic, Inc. | 2020-07-23 |
| Adapta, Versa, Sensia IPG, Relia IPG (P980035/S631) | Medtronic, Inc. | 2020-07-22 |
| Myocardial Pacing Lead (P120017/S022) | Medtronic, Inc. | 2020-07-22 |
| Sapien 3 and Sapien 3 Ultra Transcatheter Heart Valves (P140031/S107) | Edwards Lifesciences, LLC | 2020-07-22 |
| CapSureFix MRI Lead (P090013/S306) | Medtronic, Inc. | 2020-07-22 |
| Micra AV TPS, Micra TPS (P150033/S076) | Medtronic, Inc. | 2020-07-22 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S149) | Medtronic, Inc. | 2020-07-22 |
| Attain StarFix Lead (P060039/S100) | Medtronic, Inc. | 2020-07-22 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator S-ICD (P110042/S139) | Boston Scientific Corporation | 2020-07-22 |
| 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/S707) | Medtronic Cardiac Rhythm Disease Management | 2020-07-22 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead (P010015/S441) | Medtronic, Inc. | 2020-07-22 |
| 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/S747) | Medtronic Cardiac Rhythm Disease Management | 2020-07-22 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S212) | Medtronic, Inc. | 2020-07-22 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adapter kit, IS-1 Connector Port Pin Plug Kit, Lead Ad (P920015/S244) | Medtronic, Inc. | 2020-07-22 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S432) | Medtronic, Inc. | 2020-07-22 |
| Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System (P980033/S058) | Boston Scientific Corporation | 2020-07-22 |
| CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S182) | Medtronic Cardiac Rhythm Disease Management | 2020-07-22 |
| Wallstent (Tips) Endoprosthesis With Unistep Plus Delivery System (P930031/S068) | Boston Scientific Corp | 2020-07-22 |
| CapSure Epicardial Pacing Lead (P950024/S093) | Medtronic, Inc. | 2020-07-22 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S117) | Edwards Lifesciences, LLC | 2020-07-22 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S046) | Edwards Lifesciences, LLC | 2020-07-22 |
| Transvene CS/SVC Lead (P980050/S127) | Medtronic, Inc. | 2020-07-22 |
| EPIC Self Expanding Stent System (P110035/S061) | Boston Scientific Corp | 2020-07-22 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S148) | Medtronic Cardiac Rhythm Disease Management | 2020-07-22 |
| Wallstent Iliac Endoprosthesis With Unistep Plus Delivery System (P940019/S059) | Boston Scientific Scimed, Inc. | 2020-07-22 |
| ACE Header, End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S159) | Medtronic Cardiac Rhythm Disease Management | 2020-07-22 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S110) | Edwards Lifesciences, LLC | 2020-07-22 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S121) | Medtronic Cardiac Rhythm Disease Management | 2020-07-22 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD (P980016/S746) | Medtronic Cardiac Rhythm Disease Management | 2020-07-21 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, and Crome MRI CRT-D (P010031/S706) | Medtronic Cardiac Rhythm Disease Management | 2020-07-21 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device (P130013/S035) | Boston Scientific Corp | 2020-07-21 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S035) | Boston Scientific Corp | 2020-07-20 |
| HeartWare Ventricular Assist System (P100047/S168) | Medtronic | 2020-07-20 |
| Innova Vascular Self-Expanding Stent System (P140028/S062) | Boston Scientific Corporation | 2020-07-20 |
| HeartSine samaritan Public Access Automated External Defibrillators and Accessories (P160008/S012) | Heartsine Technologies, Ltd. | 2020-07-17 |
| nGEN Pump (P990071/S044) | Biosense Webster, Inc. | 2020-07-17 |
| HeartStart FRx Defibrillator (861304) (P180028/S001) | Philips Medical Systems | 2020-07-16 |
| Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System (P900056/S186) | Boston Scientific Corp | 2020-07-16 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S705) | Medtronic Cardiac Rhythm Disease Management | 2020-07-16 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S745) | Medtronic Cardiac Rhythm Disease Management | 2020-07-16 |
| HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (P160029/S004) | Philips Medical Systems, Inc. | 2020-07-16 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, Dual-Chamber and Defibrillator, Automatic (P050023/S147) | Biotronik, Inc. | 2020-07-16 |
| Coseal Surgical Sealant (P030039/S025) | Baxter Bio Science | 2020-07-16 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S147) | Medtronic, Inc. | 2020-07-15 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S079) | W. L. Gore & Associates, Inc. | 2020-07-15 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S078) | W. L. Gore & Associates, Inc. | 2020-07-15 |
| HeartWare Ventricular Assist System (P100047/S167) | Medtronic | 2020-07-15 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S139) | W. L. Gore & Associates, Inc. | 2020-07-15 |
| Diamondback 360 Coronary Orbital Atherectomy System (OAS) (P130005/S030) | Cardiovascular Systems, Inc. | 2020-07-15 |
| LIFEPAK CR2 Defibrillator (P170018/S005) | Physio-Control, Inc. | 2020-07-13 |
| Evolut PRO+ TAV of the Evolut PRO+ System, Evolut PRO TAV of the Evolut PRO System, Evolut R TAV of the Evolut R System (P130021/S079) | Medtronic, Inc. | 2020-07-13 |
| THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter and THERMOCOOL SMARTTOUCH Navigation Catheter (P040036/S075) | Biosense Webster, Inc. | 2020-07-10 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S033) | Boston Scientific Corp | 2020-07-10 |
| THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter and THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Cath (P030031/S107) | Biosense Webster, Inc. | 2020-07-10 |
| KONECT RESILIA Aortic Valved Conduit AVC (P150048/S029) | Edwards Lifesciences, LLC | 2020-07-10 |
| Impella RP System (P170011/S024) | Abiomed, Inc. | 2020-07-10 |
| CapSureFix Novus Lead (P930039/S213) | Medtronic, Inc. | 2020-07-10 |
| CapSureFix MRI Lead (P090013/S307) | Medtronic, Inc. | 2020-07-10 |
| CapSure Sense Lead (P830061/S183) | Medtronic Cardiac Rhythm Disease Management | 2020-07-10 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S029) | ABBOTT MEDICAL | 2020-07-10 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, Impella 5.0, and Impella LD Systems (P140003/S073) | Abiomed, Inc. | 2020-07-10 |
| Ovation iX Abdominal Stent Graft System (P120006/S036) | Endologix, LLC | 2020-07-09 |
| Gore TAG Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S115) | W. L. Gore & Associates, Inc. | 2020-07-09 |
| HeartWare HVAD System (P100047/S132) | Medtronic | 2020-07-09 |
| Amplatzer Piccolo Occluder (P020024/S062) | ABBOTT MEDICAL | 2020-07-09 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S018) | Physio-Control, Inc. | 2020-07-09 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S440) | Medtronic, Inc. | 2020-07-08 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S629) | Medtronic, Inc. | 2020-07-08 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, and Crome MRI CRT-D (P010031/S704) | Medtronic Cardiac Rhythm Disease Management | 2020-07-08 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD (P980016/S743) | Medtronic Cardiac Rhythm Disease Management | 2020-07-08 |
| ZOLL R Series (P160022/S017) | ZOLL Medical Corporation | 2020-07-07 |
| LATITUDE Programming System (P910077/S178) | Boston Scientific | 2020-07-07 |
| EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System (P110042/S137) | Boston Scientific Corporation | 2020-07-07 |
| ACUITY X4 (P010012/S520) | Boston Scientific Corp | 2020-07-07 |
| RELIANCE 4-FRONT (P910073/S157) | Boston Scientific | 2020-07-07 |
| GORE CARDIOFORM ASD Occluder (P050006/S083) | W. L. Gore & Associates, Inc. | 2020-07-02 |
| LifeVest Wearable Defibrillator (P010030/S140) | Zoll Manufacturing Corporation | 2020-07-02 |
| HeartLight Catheter and HeartLight Console (P150026/S011) | Cardiofocus, Inc. | 2020-07-01 |
| REBEL Platinum Chromium Coronary Stent System Monorail and Over-the-Wire (P130030/S069) | Boston Scientific Corp | 2020-07-01 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S050) | ABBOTT MEDICAL | 2020-06-30 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S423) | ABBOTT MEDICAL | 2020-06-30 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S374) | ABBOTT MEDICAL | 2020-06-30 |