| Wallstent (Tips) Endoprosthesis with Unistep Plus Delivery System (P930031/S062) | Boston Scientific Corp | 2018-12-17 |
| IsoFlex Low Voltage Passive (P960030/S065) | ABBOTT MEDICAL | 2018-12-17 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008/S003) | Heartsine Technologies, Ltd. | 2018-12-17 |
| Wallstent (Venous) Endoprosthesis with Unistep Plus Delivery System (P980033/S052) | Boston Scientific Corporation | 2018-12-17 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead (P850089/S139) | Medtronic Cardiac Rhythm Disease Management | 2018-12-17 |
| Sprint Quattro Lead (P920015/S224) | Medtronic, Inc. | 2018-12-17 |
| CapSure VDD 2 Lead and Vitatron Brilliant S+ VDD Lead (P890003/S402) | Medtronic, Inc. | 2018-12-17 |
| OpticSense, Tendril STS, SDX, ST Low Voltage Active (P960013/S106) | ABBOTT MEDICAL | 2018-12-17 |
| Durata, Optisure High Voltage Passive, High Voltage Active (P950022/S126) | ABBOTT MEDICAL | 2018-12-17 |
| CapSure Epicardial Pacing Lead (P950024/S083) | Medtronic, Inc. | 2018-12-17 |
| CapSureFix MRI Lead (P090013/S295) | Medtronic, Inc. | 2018-12-17 |
| Quickflex u, Quartet Cardiac Resynchronization Therapy Passive (P030054/S367) | ABBOTT MEDICAL | 2018-12-17 |
| Innova Self-Expanding Stent System (P140028/S034) | Boston Scientific Corporation | 2018-12-14 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S161) | W. L. Gore & Associates, Inc. | 2018-12-14 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S012) | Medtronic Vascular | 2018-12-14 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S088) | Medtronic Vascular | 2018-12-14 |
| Synergy Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S044) | Boston Scientific Corporation | 2018-12-14 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S002) | Boston Scientific Corp | 2018-12-14 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device and Delivery System (P130013/S023) | Boston Scientific Corp | 2018-12-14 |
| GORE TIGIRIS Vascular Stent (P160004/S023) | W. L. Gore & Associates, Inc. | 2018-12-13 |
| Tendril STS 2088TC Lead (P140033/S033) | ABBOTT MEDICAL | 2018-12-13 |
| Tendril STS 2088TC Lead (P910023/S410) | ABBOTT MEDICAL | 2018-12-13 |
| GORE Carotid Stent (P180010/S001) | W. L. Gore & Associates, Inc. | 2018-12-13 |
| Tendril STS 2088TC Lead (P960013/S098) | ABBOTT MEDICAL | 2018-12-13 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S063) | W. L. Gore & Associates, Inc. | 2018-12-13 |
| Defibrillator, Automatic Implantable Cardioverter with Cardiac Resynchronization (CRT-D) (P050023/S127) | Biotronik, Inc. | 2018-12-13 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S124) | W. L. Gore & Associates, Inc. | 2018-12-13 |
| Tendril STS 2088TC Lead (P030054/S355) | ABBOTT MEDICAL | 2018-12-13 |
| GORE VIABAHN Balloon Expandable Endoprosthesis (P160021/S015) | W. L. Gore & Associates, Inc. | 2018-12-13 |
| Assurity MRI and Endurity MRI, MRI Activator, and Tendril MRI (P140033/S042) | ABBOTT MEDICAL | 2018-12-13 |
| Implantable Cardioverter Defibrillatory (Non-CRT) and Defibrillatort, Implantable, Dual-Chamber (P980023/S088) | Biotronik, Inc. | 2018-12-13 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet, and Quartet CRT Leads (P030054/S365) | ABBOTT MEDICAL | 2018-12-12 |
| RF Enhancr II Catheter (P930029/S064) | Medtronic, Inc. | 2018-12-12 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S160) | W. L. Gore & Associates, Inc. | 2018-12-12 |
| Allure, Allure Quadra and Quadra Allure MP (P030035/S176) | ABBOTT MEDICAL | 2018-12-11 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S003) | Boston Scientific Corp | 2018-12-11 |
| Microny Pacemaker (P970013/S080) | ABBOTT MEDICAL | 2018-12-11 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL and Sustain XL DC, S (P880086/S305) | ABBOTT MEDICAL | 2018-12-11 |
| Tendril SDX Lead, Tendril ST Lead, OptiSense and Tendril STS Lead (P960013/S104) | ABBOTT MEDICAL | 2018-12-11 |
| Innova Vascular Self-Expanding Stent System (P140028/S035) | Boston Scientific Corporation | 2018-12-11 |
| Watchman Left Atrial Appendage (LLAC) Closure Technology (P130013/S024) | Boston Scientific Corp | 2018-12-11 |
| Durata and Optisure (P950022/S124) | ABBOTT MEDICAL | 2018-12-11 |
| IsoFlex Optim (P960030/S063) | ABBOTT MEDICAL | 2018-12-11 |
| Cortify, Fortify Assura, and Ellipse (P910023/S415) | ABBOTT MEDICAL | 2018-12-11 |
| Express SD Renal Monorail Premounted Stent System (P060006/S095) | Boston Scientific Corp | 2018-12-10 |
| Astra S DR, S SR MRI IPG, Astra XT DR,SR MRI IPG; Azure S DR,S SR MRI IPG, Azure XT DR,SR MRI IPG. (P980035/S573) | Medtronic, Inc. | 2018-12-10 |
| Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3 (P160033) | ZOLL Medical Corporation | 2018-12-07 |
| SJM Masters HP 15mm Rotatable Mechanical Heart Valve (15 AHPJ-505) (P810002/S107) | ABBOTT MEDICAL | 2018-12-07 |
| Gore CardioForm Septal Occluder (P050006/S067) | W. L. Gore & Associates, Inc. | 2018-12-07 |
| Venaseal Closure System (P140018/S014) | Medtronic Vascular, Inc. | 2018-12-07 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve (TAV) (P130021/S057) | Medtronic, Inc. | 2018-12-06 |
| EMBLEM S-ICD Pulse Generator; EMBLEM MRI S-ICD Pulse Generator (P110042/S117) | Boston Scientific Corporation | 2018-12-06 |
| Medtronic CoreValve Evolut PRO TAV, and Avalus Bioprosthesis (P170006/S008) | Medtronic, Inc. | 2018-12-06 |
| CRT-Ds (Cardiac Resynchronization Therapy Defibrillator) Platinium (P060027/S097) | MicroPort CRM USA, Inc. | 2018-12-06 |
| ICDs (Implantable Cardioverter Defibrillator) Platinium VR/DR (P980049/S132) | MicroPort CRM USA, Inc. | 2018-12-06 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S001) | Defibtech, LLC | 2018-12-06 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S001) | Boston Scientific Corp | 2018-12-06 |
| Powerheart® AED G3 Pro (P160034) | ZOLL Medical Corporation | 2018-12-06 |
| LIFEPAK 15 monitor/defibrillator (P160026/S003) | Physio-Control, Inc. | 2018-12-06 |
| Durata, Optisure High Voltage Active and Passive Leads (P950022/S125) | ABBOTT MEDICAL | 2018-12-05 |
| Tendril MRI Low Voltage Leads (P140033/S043) | ABBOTT MEDICAL | 2018-12-05 |
| Tendril SDX, OptiSense, Tendril STS and Tendril ST Low Voltage Active Fixation Leads (P960013/S105) | ABBOTT MEDICAL | 2018-12-05 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, SPhera DR MRI IPG, and Sphera SR MRI IPG (P980035/S572) | Medtronic, Inc. | 2018-12-05 |
| QuickFlex u, Quartet Cardiac Resynchronization Therapy (CRT) Passive Fixation Leads (P030054/S366) | ABBOTT MEDICAL | 2018-12-05 |
| Isoflex Low Voltage Passive Fixation Leads (P960030/S064) | ABBOTT MEDICAL | 2018-12-05 |
| Watchman LAA Closure Technology (P130013/S022) | Boston Scientific Corp | 2018-12-04 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S387) | Medtronic, Inc. | 2018-12-03 |
| 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/S656) | Medtronic Cardiac Rhythm Disease Management | 2018-12-03 |
| 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, A (P980035/S571) | Medtronic, Inc. | 2018-12-03 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Protecta ICD, Protecta VR/XT ICD, Secura DR IC (P980016/S697) | Medtronic Cardiac Rhythm Disease Management | 2018-12-03 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S079) | Edwards Lifesciences, LLC | 2018-12-03 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S294) | Medtronic, Inc. | 2018-12-03 |
| Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve (P150048/S030) | Edwards Lifesciences, LLC | 2018-12-03 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S095) | Edwards Lifesciences, LLC | 2018-12-03 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis/Theon Pericardial Aortic Bioprosthesis with ThermaFix tiss (P860057/S186) | Edwards Lifesciences, LLC | 2018-12-03 |
| EDWARDS INTUITY Elite Valve System (P150036/S035) | Edwards Lifesciences, LLC | 2018-12-03 |
| Carpentier-Edwards PERIMOUNT Plus Pericardial Mitral Bioprosthesis/Theon Pericardial Mitral Bioprosthesis with ThermaFix (P860057/S185) | Edwards Lifesciences, LLC | 2018-12-01 |
| EDWARDS INTUITY ELITE Valve/Delivery System (P150036/S036) | Edwards Lifesciences, LLC | 2018-12-01 |
| Impella CP with SmartAssist (P140003/S043) | Abiomed, Inc. | 2018-11-30 |
| Impella CP with SmartAssist (P140003/S042) | Abiomed, Inc. | 2018-11-30 |
| Micra Transcatheter Pacing System (P150033/S047) | Medtronic, Inc. | 2018-11-29 |
| EMBLEM S-ICD PG Models A209 and A219 (P110042/S118) | Boston Scientific Corporation | 2018-11-29 |
| SelectSecure Lead (P030036/S107) | Medtronic Cardiac Rhythm Disease Management | 2018-11-28 |
| Blazer II, Blazer II HTD, Blazer Prime HTD (P920047/S113) | Boston Scientific Corp | 2018-11-28 |
| Evera 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 ICD, Prot (P980016/S696) | Medtronic Cardiac Rhythm Disease Management | 2018-11-28 |
| Blazer II XP and Blazer Prime XP (P020025/S116) | Boston Scientific | 2018-11-28 |
| HV Splitter/Adaptor Kit and Sprint Quattro Lead (P920015/S223) | Medtronic, Inc. | 2018-11-28 |
| 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/S570) | Medtronic, Inc. | 2018-11-28 |
| 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/S655) | Medtronic Cardiac Rhythm Disease Management | 2018-11-28 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S386) | Medtronic, Inc. | 2018-11-28 |
| VASCADE MVP Venous Vascular Closure System (VVCS) (P120016/S024) | Cardiva Medical, Inc. | 2018-11-27 |
| INCRAFT(R) AAA STENT GRAFT SYSTEM (P150002) | Cordis US Corporation | 2018-11-27 |
| Gore Tigris Vascular Stent (P160004/S022) | W. L. Gore & Associates, Inc. | 2018-11-26 |
| RF Marinr Catheters (P930029/S063) | Medtronic, Inc. | 2018-11-26 |
| Medtronic CareLink Model 9986 (2090 CareLink Programmer), Model SW028 (29901 Encore Programmer) (P890003/S396) | Medtronic, Inc. | 2018-11-21 |
| EDWARDS INTUITY Elite Valve System (P150036/S033) | Edwards Lifesciences, LLC | 2018-11-20 |
| Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve (P150048/S027) | Edwards Lifesciences, LLC | 2018-11-20 |
| XIENCE Sierra RX Everolimus Eluting Coronary Stent System (P110019/S103) | Abbott Vascular | 2018-11-20 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S068) | W. L. Gore & Associates, Inc. | 2018-11-20 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S183) | Edwards Lifesciences, LLC | 2018-11-20 |