| HeartWare Ventricular Assist System (P100047/S119) | Medtronic | 2018-04-24 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S355) | Medtronic, Inc. | 2018-04-24 |
| Brava CRT-D, Brava Quad CRT-D, Concerto ICD, Concerto II CRT-D, Consulta CRT-D, InSync II Protect ICD, Maximo II CRT-D, (P010031/S618) | Medtronic Cardiac Rhythm Disease Management | 2018-04-24 |
| VenaSeal Closure System (P140018/S011) | Medtronic Vascular, Inc. | 2018-04-24 |
| Micra (P150033/S032) | Medtronic, Inc. | 2018-04-24 |
| Attain Ability and Performa Lead (P080006/S120) | Medtronic, Inc. | 2018-04-23 |
| Attain StarFix Lead (P060039/S086) | Medtronic, Inc. | 2018-04-23 |
| Sprint Quattro Lead (P920015/S211) | Medtronic, Inc. | 2018-04-23 |
| CapSure Sense Lead, CapSure SP Novus Lead, and VItatron Crystalline Lead (P830061/S156) | Medtronic Cardiac Rhythm Disease Management | 2018-04-23 |
| CapSureFix MRI Lead (P090013/S277) | Medtronic, Inc. | 2018-04-23 |
| Attain StarFix Lead (P060039/S085) | Medtronic, Inc. | 2018-04-23 |
| Attain Bipolar OTW Lead and Attain OTW LV Lead (P010015/S364) | Medtronic, Inc. | 2018-04-23 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead (P850089/S132) | Medtronic Cardiac Rhythm Disease Management | 2018-04-23 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S155) | Medtronic Cardiac Rhythm Disease Management | 2018-04-23 |
| CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S388) | Medtronic, Inc. | 2018-04-23 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S183) | Medtronic, Inc. | 2018-04-23 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead (P010015/S362) | Medtronic, Inc. | 2018-04-23 |
| Artic Front Advance Cardiac CryoAblation Catheters (P100010/S077) | Medtronic Cryocath, LP | 2018-04-23 |
| CapSure VDD 2 Lead and Vitatron Brilliant S+ VDD Lead (P890003/S389) | Medtronic, Inc. | 2018-04-23 |
| Transvene CS/SVC Lead (P980050/S116) | Medtronic, Inc. | 2018-04-23 |
| Sprint Quattro Lead, Transvene CS/SVC Lead (P920015/S210) | Medtronic, Inc. | 2018-04-23 |
| Transvene CS/SVC Lead (P980050/S115) | Medtronic, Inc. | 2018-04-23 |
| Sprint Quattro Lead, Subcutaneous Lead and Transvene CS/SVS Lead (P920015/S212) | Medtronic, Inc. | 2018-04-23 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S131) | Medtronic Cardiac Rhythm Disease Management | 2018-04-23 |
| CapSureFix MRI Lead (P090013/S274) | Medtronic, Inc. | 2018-04-23 |
| Attain Ability Lead, Attain Performa Lead (P080006/S119) | Medtronic, Inc. | 2018-04-23 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S185) | Medtronic, Inc. | 2018-04-23 |
| CapSureFix MRI Lead (P090013/S276) | Medtronic, Inc. | 2018-04-23 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S184) | Medtronic, Inc. | 2018-04-23 |
| TRIDYNE Vascular Sealant (P150016/S012) | Neomend, Inc. | 2018-04-20 |
| Emblem S-ICD Electrode Delivery System (model 4712) (P110042/S102) | Boston Scientific Corporation | 2018-04-19 |
| Biocor Valve, Epic Valve, Epic Supra Valve (P040021/S035) | ABBOTT MEDICAL | 2018-04-19 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S004) | Bard Peripheral Vascular, Inc. | 2018-04-19 |
| Sprint Quattro Lead (6935M), Sprint Quattro Lead (6935) (P920015/S206) | Medtronic, Inc. | 2018-04-19 |
| Hancock II Porcine Bioprosthesis (P980043/S066) | Medtronic, Inc. | 2018-04-19 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous-Transluminal Angioplasty Balloon Catheter (P140010/S037) | Medtronic, Inc. | 2018-04-19 |
| Hancock Low Porosity Valved Conduit (P870078/S041) | Medtronic, Inc. | 2018-04-19 |
| Lead Cap Kit (model 7007) (P910073/S146) | Boston Scientific | 2018-04-19 |
| Mosaic Procine Bioprosthesis (P990064/S075) | Medtronic, Inc. | 2018-04-19 |
| Freestyle Aortic Root Bioprosthesis (P970031/S063) | Medtronic, Inc. | 2018-04-19 |
| Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S033) | ABBOTT MEDICAL | 2018-04-19 |
| Hancock Modified Orifice Valved Conduit (P790007/S056) | Medtronic Heart Valves | 2018-04-19 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S086) | Medtronic Vascular | 2018-04-18 |
| Enroute Transcarotid Stent System (P140026/S009) | Boston Scientific Corporation | 2018-04-18 |
| Freezor Cardiac CryoAblation Catheter, Freezor Xtra Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation (P020045/S086) | Medtronic Cryocath, LP | 2018-04-17 |
| Arctic Front Cardiac CryoAblation Catheter and Arctic Front Advance Cardiac CryoAblation Catheter (P100010/S073) | Medtronic Cryocath, LP | 2018-04-17 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S002) | Medinol, Ltd. | 2018-04-17 |
| Nirxcell CoCr Coronary Stent on RX System (P110004/S028) | Medinol, Ltd. | 2018-04-17 |
| Life Vest Wearable Defibrillator (P010030/S102) | Zoll Manufacturing Corporation | 2018-04-17 |
| Gore Cardioform Septal Occluder (P050006/S064) | W. L. Gore & Associates, Inc. | 2018-04-17 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S089) | Medtronic Vascular | 2018-04-16 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S001) | Celonova Biosciences, Inc. | 2018-04-16 |
| Adapta, Versa, Sensia IPG, Attesta IPG, Relia IPG, Sphera IPG (P980035/S542) | Medtronic, Inc. | 2018-04-16 |
| Impella CP System (P140003/S031) | Abiomed, Inc. | 2018-04-16 |
| Xience Prime, Xience Prime SV, Xience Prime LL, Xience Xpedition, Xience Xpedition SV, Xience Xpedition LL, Xience Alpin (P110019/S100) | Abbott Vascular | 2018-04-16 |
| HeartLight Endoscopic Ablation System (P150026/S004) | Cardiofocus, Inc. | 2018-04-16 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S015) | Medtronic Vascular | 2018-04-16 |
| StarClose SE Vascular Closure System (P050007/S035) | Abbott Vascular Devices | 2018-04-16 |
| Resolute Onyx Zotarolimus-eluting Coronary Stent Systems (P160043/S014) | Medtronic Vascular | 2018-04-16 |
| Xience V Everolimus Eluting Coronary Stent System, Xience nano Everolimus Eluting Coronary Stent System (P070015/S142) | Abbott Vascular, Inc. | 2018-04-16 |
| Gore Tigris Vascular Stent (P160004/S008) | W. L. Gore & Associates, Inc. | 2018-04-13 |
| HeartWare Ventricular Assist System (P100047/S118) | Medtronic | 2018-04-13 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S361) | Medtronic, Inc. | 2018-04-12 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S182) | Medtronic, Inc. | 2018-04-12 |
| Edwards Intuity Elite Valve System (P150036/S028) | Edwards Lifesciences, LLC | 2018-04-12 |
| Edwards Pericardial Aortic Bioprothesis, Inspiris Resilia Aortic Valve (P150048/S019) | Edwards Lifesciences, LLC | 2018-04-12 |
| Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S543) | Medtronic, Inc. | 2018-04-12 |
| CapSureFix MRI Lead (P090013/S273) | Medtronic, Inc. | 2018-04-12 |
| Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Perimount Theon Pericardial Aortic Bioprothesis with Ther (P860057/S177) | Edwards Lifesciences, LLC | 2018-04-12 |
| Edwards Sapien 3 Transcatheter Heart Valve (P140031/S062) | Edwards Lifesciences, LLC | 2018-04-12 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S087) | Edwards Lifesciences, LLC | 2018-04-12 |
| Accolade, Altrua 2, Essentio, Proponent (N970003/S227) | Boston Scientific Corp | 2018-04-11 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+family of ICDS (P910023/S400) | ABBOTT MEDICAL | 2018-04-11 |
| Accolade MRI, Essentio MRI, Proponent MRI (P150012/S055) | Boston Scientific | 2018-04-11 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S344) | ABBOTT MEDICAL | 2018-04-11 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S293) | ABBOTT MEDICAL | 2018-04-11 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S164) | ABBOTT MEDICAL | 2018-04-11 |
| Assurity MRI Endurity MRI family of Pacemakers (P140033/S022) | ABBOTT MEDICAL | 2018-04-11 |
| Microny family of Pacemakers (P970013/S076) | ABBOTT MEDICAL | 2018-04-11 |
| 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/S621) | Medtronic Cardiac Rhythm Disease Management | 2018-04-10 |
| Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR/SR MRI IPG; Astra XT DR MRI IPG; Astra S DR/SR MRI IPG; Astra XT SR (P980035/S540) | Medtronic, Inc. | 2018-04-10 |
| Revo MRI SureScan IPG (P090013/S272) | Medtronic, Inc. | 2018-04-10 |
| NG2.5 (Dynagen Mini/Inogen Mini/ Origen Mini), Pervica ICD Pulse Generator (P960040/S424) | Boston Scientific | 2018-04-10 |
| 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; Visi (P980016/S661) | Medtronic Cardiac Rhythm Disease Management | 2018-04-10 |
| Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (P010015/S360) | Medtronic, Inc. | 2018-04-10 |
| Micra TPS (P150033/S033) | Medtronic, Inc. | 2018-04-10 |
| Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI IPG (P980035/S539) | Medtronic, Inc. | 2018-04-09 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S359) | Medtronic, Inc. | 2018-04-09 |
| Guardian System (P150009) | Avertix Medical, Inc. | 2018-04-09 |
| 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/S662) | Medtronic Cardiac Rhythm Disease Management | 2018-04-09 |
| FlexAbility Catheter, Sensor Enabled (P110016/S056) | ABBOTT MEDICAL | 2018-04-09 |
| 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/S620) | Medtronic Cardiac Rhythm Disease Management | 2018-04-09 |
| Astra XT DR, Astra S DR, Astra S SR, Astra XT SR, Azure S DR, Azure S SR, Azure XT DR, Azure XT SR MRI IPG (P980035/S541) | Medtronic, Inc. | 2018-04-06 |
| Medtronic CoreValve System / Medtronic CoreValve Evolut R System/ Medtronic CoreValve Evolut PRO System (P130021/S041) | Medtronic, Inc. | 2018-04-06 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S029) | Medinol, Ltd. | 2018-04-05 |
| INGEVITY MRI Active Fixation Lead Models (P150012/S056) | Boston Scientific | 2018-04-05 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S003) | Medinol, Ltd. | 2018-04-05 |
| TactiCath Quartz Set (P130026/S033) | St Jude Medical | 2018-04-04 |
| CardioMEMS HF System (P100045/S023) | ABBOTT MEDICAL | 2018-04-04 |
| Unify CD3231-40, CD3231-40Q; Unify Quadra CD3249-40, CD3249-40Q; Unify Assura CD3257-40, CD3257-40Q, CD3357-40, CD3357-4 (P030054/S351) | ABBOTT MEDICAL | 2018-04-04 |