| Express SD Monorail Premounted Stent System (P060006/S098) | Boston Scientific Corp | 2019-11-07 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S062) | Boston Scientific Corp | 2019-11-07 |
| PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System (P110010/S171) | Boston Scientific Corp | 2019-11-07 |
| WOLVERINE Coronary Cutting Balloon (P950020/S099) | Boston Scientific Corp | 2019-11-07 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S050) | Boston Scientific Corp | 2019-11-07 |
| CoreValve Evolut R System, CoreValve Evolut PRO System, and CoreValve Evolut PRO + System (P130021/S068) | Medtronic, Inc. | 2019-11-07 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S091) | Boston Scientific Corp | 2019-11-07 |
| HeartWare HVAD System (P100047/S131) | Medtronic | 2019-11-06 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S101) | Edwards Lifesciences, LLC | 2019-11-04 |
| Excor Pediatric Ventricular Assist Device (P160035/S011) | Berlin Heart, Inc. | 2019-11-03 |
| Excor Pediatric Ventricular Assist Device (P160035/S012) | Berlin Heart, Inc. | 2019-11-03 |
| 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/S682) | Medtronic Cardiac Rhythm Disease Management | 2019-11-01 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S D (P980035/S606) | Medtronic, Inc. | 2019-11-01 |
| 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/S721) | Medtronic Cardiac Rhythm Disease Management | 2019-11-01 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S420) | Medtronic, Inc. | 2019-11-01 |
| Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S170) | Boston Scientific Corp | 2019-11-01 |
| Zenith Dissection Endovascular System (P180001/S001) | William Cook Europe Aps | 2019-10-31 |
| GORE CARDIOFORM ASD Occluder and Septal Occluder (P050006/S080) | W. L. Gore & Associates, Inc. | 2019-10-31 |
| Covera Vascular Covered Stent (P170042/S003) | C.R. Bard, Inc. | 2019-10-31 |
| GORE TAG Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S113) | W. L. Gore & Associates, Inc. | 2019-10-31 |
| LOTUS Edge Valve System (P180029/S008) | Boston Scientific Corporation | 2019-10-30 |
| IMPELLA 2.5 System, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella 5.5 with SmartAssist and Impella LD (P140003/S061) | Abiomed, Inc. | 2019-10-30 |
| Enveo R and EnVeo PRO Delivery Catheter System of the CoreValve (P130021/S065) | Medtronic, Inc. | 2019-10-30 |
| VICI VENOUS STENT System (P180013/S001) | Boston Scientific Corporation | 2019-10-30 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S024) | Bolton Medical, Inc. | 2019-10-30 |
| Evolut R and CoreValve Evolut PRO Systems (P140017/S017) | Medtronic, Inc. | 2019-10-30 |
| Impella RP System (P170011/S017) | Abiomed, Inc. | 2019-10-30 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S130) | Boston Scientific Corporation | 2019-10-29 |
| Cardiac Resynchronization Therapy - Pacemaker (CRT-P) (P030005/S190) | Guidant Corp. | 2019-10-29 |
| Implantable Cardioverter Defibrillator (ICD) (P960040/S443) | Boston Scientific | 2019-10-29 |
| CardioMEMS HF System (P100045/S040) | ABBOTT MEDICAL | 2019-10-29 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) (P010012/S510) | Boston Scientific Corp | 2019-10-29 |
| Non-MRI Pacemakers (N970003/S244) | Boston Scientific Corp | 2019-10-29 |
| CoreValve Evolut R and Evolut PRO Systems (P130021/S066) | Medtronic, Inc. | 2019-10-29 |
| MRI Pacemakers (P150012/S084) | Boston Scientific | 2019-10-29 |
| Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Valve, and Edwards Pericardial Mitral Bioprosthesis (P150048/S039) | Edwards Lifesciences, LLC | 2019-10-28 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S103) | Edwards Lifesciences, LLC | 2019-10-28 |
| Edwards Intuity Elite Valve (P150036/S043) | Edwards Lifesciences, LLC | 2019-10-28 |
| Perimount Bioprosthesis, Perimount Magna Aortic Bioprosthesis, Perimount Magna Ease Bioprosthesis, and Perimount Plus Bi (P860057/S192) | Edwards Lifesciences, LLC | 2019-10-28 |
| Edwards Sapien 3 Transcatheter Heart Valve and Edward Sapien 3 Ultra Transcatheter Heart Valve (P140031/S098) | Edwards Lifesciences, LLC | 2019-10-28 |
| TactiCath Quartz Contact Force Ablation Catheter and TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S052) | St Jude Medical | 2019-10-25 |
| Amplatzer Septal Occluder and Amplatzer Multi-Fenestrated Septal Occluder (P000039/S068) | ABBOTT MEDICAL | 2019-10-25 |
| LIFEPAK 20e Defibrillator/Monitor (P160026/S010) | Physio-Control, Inc. | 2019-10-25 |
| Tendril ST/STS Steroid Eluting Cardiac Leads (P960013/S108) | ABBOTT MEDICAL | 2019-10-25 |
| Amplatzer PFO Occluder (P120021/S013) | ABBOTT MEDICAL | 2019-10-25 |
| Livewire TC Ablation, Livewire TC Cables, Safire Ablation Catheter and Safire Cables (P960016/S080) | St Jude Medical | 2019-10-25 |
| Amplatzer Muscular VSD Occluder (P040040/S038) | ABBOTT MEDICAL | 2019-10-25 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Septal Occluder (P020024/S058) | ABBOTT MEDICAL | 2019-10-25 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S004) | Biotronik AG | 2019-10-25 |
| FlexAbility and FlexAbility SE Ablation Catheter and FlexAbility Cables, Sensor Enabled (P110016/S065) | ABBOTT MEDICAL | 2019-10-25 |
| TENDRIL MRI (P140033/S047) | ABBOTT MEDICAL | 2019-10-24 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S171) | W. L. Gore & Associates, Inc. | 2019-10-24 |
| TENDRIL, OPTISENSE (P960013/S109) | ABBOTT MEDICAL | 2019-10-24 |
| Durata and Optisure HV Active Steroid Eluting Cardiac Leads (P950022/S128) | ABBOTT MEDICAL | 2019-10-24 |
| ISOFLEX (P960030/S067) | ABBOTT MEDICAL | 2019-10-24 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S009) | Berlin Heart, Inc. | 2019-10-23 |
| Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S141) | Medtronic, Inc. | 2019-10-23 |
| LIFEPAK® CR2 Defibrillator (P170018/S004) | Physio-Control, Inc. | 2019-10-23 |
| OPTIMIZER Smart System (P180036/S003) | Impulse Dynamics (Usa), Inc. | 2019-10-23 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S096) | Medtronic Vascular | 2019-10-22 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S025) | Medtronic Vascular | 2019-10-22 |
| TactiCath Quartz Catheter Contact Force Ablation Catheter (P130026/S053) | St Jude Medical | 2019-10-22 |
| HeartWare HVAD System (P100047/S139) | Medtronic | 2019-10-21 |
| LifeVest Wearable Defibrillator (P010030/S126) | Zoll Manufacturing Corporation | 2019-10-21 |
| Spectranetics Laser Sheaths SLS (P960042/S068) | Spectranetics (Philips) | 2019-10-21 |
| CVX-3000 Excimer Lasert System and ELCA Coronary Atherectomy Catheters (P910001/S110) | Spectranetics Corp. | 2019-10-21 |
| Pacemaker Devices: ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, and PROPONENT (N970003/S242) | Boston Scientific Corp | 2019-10-18 |
| CRT-D Resynchronization Devices: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM (P010012/S508) | Boston Scientific Corp | 2019-10-18 |
| HeartWare HVAD System (P100047/S148) | Medtronic | 2019-10-18 |
| LATITUDE Programming System, Brady v1.06 with Heart Connect (P910077/S173) | Boston Scientific | 2019-10-18 |
| Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI (P150012/S081) | Boston Scientific | 2019-10-18 |
| Assurity MRI Pacemakers and Endurity MRI Pacemakers (P140033/S031) | ABBOTT MEDICAL | 2019-10-18 |
| Ellipse hybrid (P910023/S420) | ABBOTT MEDICAL | 2019-10-18 |
| Assurity Pacemaker & Endurity Pacemaker (P880086/S299) | ABBOTT MEDICAL | 2019-10-18 |
| ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC (P960040/S441) | Boston Scientific | 2019-10-18 |
| CRT-P Resynchronization Devices: INVIVE, INTUA, VISIONIST, and VALITUDE (P030005/S188) | Guidant Corp. | 2019-10-18 |
| WATCHMAN Left Atrial Appendage Closure Device (P130013/S033) | Boston Scientific Corp | 2019-10-18 |
| Arctic Front Advance Pro and Arctic Front Advance Cardiac Cryoablation Catheters (P100010/S097) | Medtronic Cryocath, LP | 2019-10-18 |
| Pulse Generator, Permanent Implantable, Pulse-Gererator, Pacemaker External, Adapter and Drug Eluting Permanent Right Ve (P950037/S205) | Biotronik, Inc. | 2019-10-18 |
| Pulse Generator, Pacemaker Implantble with Cardiac Resynchronization (CRT-P) and Drug Eluting Permanent Left Ventricular (P070008/S108) | Biotronik, Inc. | 2019-10-18 |
| Permanent Defibrillator Electrodes, Accessories to Permanent Pacemaker Electrode and Styley Catheter (P980023/S095) | Biotronik, Inc. | 2019-10-18 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, dual chamber, Defibrillator, automatic imp (P050023/S136) | Biotronik, Inc. | 2019-10-18 |
| Talent Occluder with Occluder Delivery System (P100021/S078) | Medtronic Vascular | 2019-10-17 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S098) | Medtronic Vascular | 2019-10-17 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S095) | Medtronic Vascular | 2019-10-17 |
| Edwards Expandable Introducer Sheath Set (P130009/S102) | Edwards Lifesciences, LLC | 2019-10-17 |
| Valiant Thoracic Stent Graft With the Captivia Delivery System (P100040/S039) | Medtronic Vascular | 2019-10-17 |
| Edwards eSheath Introducer Set (P140031/S097) | Edwards Lifesciences, LLC | 2019-10-17 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S024) | Medtronic Vascular | 2019-10-17 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S072) | W. L. Gore & Associates, Inc. | 2019-10-15 |
| Ellipse, Fortify, Fortify Assura and Quadra Assura MP ICD (P910023/S419) | ABBOTT MEDICAL | 2019-10-15 |
| GORE VIABAHN Endoprosthesis (P040037/S133) | W. L. Gore & Associates, Inc. | 2019-10-15 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S011) | Celonova Biosciences, Inc. | 2019-10-15 |
| Quadra Assura, Unify, Unify Assura and Unify Quadra CRT-D (P030054/S371) | ABBOTT MEDICAL | 2019-10-15 |
| LOTUS Edge Valve System (P180029/S015) | Boston Scientific Corporation | 2019-10-13 |
| Innova Vascular Self-Expanding Stent System (P140028/S044) | Boston Scientific Corporation | 2019-10-11 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S012) | Boston Scientific Corp | 2019-10-11 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus ELITE Everolimus-Eluting Platinum C (P110010/S169) | Boston Scientific Corp | 2019-10-11 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S004) | The Spectranetics Corp. | 2019-10-11 |
| LifeVest Wearable Defibrillator (P010030/S124) | Zoll Manufacturing Corporation | 2019-10-11 |