| Express SD Premounted Stent System (ESD) (P060006/S096) | Boston Scientific Corp | 2019-06-18 |
| Innova Vasculaar Self-Expanding Stent System (P140028/S040) | Boston Scientific Corporation | 2019-06-18 |
| REBEL Plantinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P130030/S060) | Boston Scientific Corp | 2019-06-18 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S008) | Boston Scientific Corp | 2019-06-18 |
| Express LD Premounted Iliac Stent System (ELD) (P090003/S047) | Boston Scientific Corporation | 2019-06-18 |
| Epic Vascular Self-Expanding Stent System (P110035/S050) | Boston Scientific Corp | 2019-06-18 |
| Synergy Everolimus-Eluting Platinum Chromium Coronaray Stent System (P150003/S047) | Boston Scientific Corporation | 2019-06-18 |
| PROMUS Element Plus Everolimus-Eluting Plaatinum Chromium Coronary Stent System (Monorail and Over-the-Wire), PROMUS PRE (P110010/S165) | Boston Scientific Corp | 2019-06-18 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI Cardiac Ablation Percutaneous Catheter (P150005/S045) | Boston Scientific Corp | 2019-06-17 |
| Protégé GPS and Protégé RX Carotid Stent Systems, and Protégé GPS Peripheral Stent Systems (P060001/S028) | Medtronic Vascular, Inc. | 2019-06-17 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S095) | Medtronic Cryocath, LP | 2019-06-17 |
| Blazer II, Blazer II HTD, Blazer II XP, Blazer Prime HTD, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav MiFi XP, Intel (P020025/S120) | Boston Scientific | 2019-06-17 |
| EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syst (P110023/S027) | Medtronic Vascular, Inc. | 2019-06-17 |
| Blazer II XP, Blazer Prime HTD, Blazer Prime XP Cardiac Ablation Percutaneous Catheter (P920047/S116) | Boston Scientific Corp | 2019-06-17 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S166) | Boston Scientific Corp | 2019-06-14 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S049) | Boston Scientific Corporation | 2019-06-14 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivey System (P130013/S029) | Boston Scientific Corp | 2019-06-13 |
| TactiSys Quartz System (P130026/S046) | St Jude Medical | 2019-06-13 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S023) | Abbott Vascular (Idef Technologies Inc) | 2019-06-13 |
| Edwards Pericradial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve (P150048/S035) | Edwards Lifesciences, LLC | 2019-06-12 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S006) | The Spectranetics Corp. | 2019-06-12 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S048) | Boston Scientific Corporation | 2019-06-11 |
| CareLink SmartSync Percepta Serena Solara Application; Percepta, Serena, Solara Quard CRT-P MRI SureScan. (P010015/S399) | Medtronic, Inc. | 2019-06-11 |
| CareLink SmartSync Host, Platform, Common Application (P890003/S407) | Medtronic, Inc. | 2019-06-11 |
| Evera MRI, Evera, Marquis, Secura Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II, Visia AF (P980016/S702) | Medtronic Cardiac Rhythm Disease Management | 2019-06-11 |
| Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S190) | Edwards Lifesciences, LLC | 2019-06-11 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S400) | Medtronic, Inc. | 2019-06-11 |
| Angio Seal Vascular Closure Devices (P930038/S096) | Terumo Medical Corporation | 2019-06-11 |
| Edwards Sapien 3 Transcatheter Heart Valve and Sapien 3 Ultra Transcatheter Heart Valve (P140031/S089) | Edwards Lifesciences, LLC | 2019-06-11 |
| Adapta, Versa, Sensia, Advisa, Advisa MRI, EnPulse, Kappa (P980035/S584) | Medtronic, Inc. | 2019-06-11 |
| Micra (P150033/S052) | Medtronic, Inc. | 2019-06-11 |
| MyCareLink Firmware (P890003/S408) | Medtronic, Inc. | 2019-06-11 |
| Viva, Brava, Protecta, XT, Concerto, Concerto II, Maximo II, InSync II Protect, Amplia, Compia, Claria (P010031/S662) | Medtronic Cardiac Rhythm Disease Management | 2019-06-11 |
| Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve (P150048/S036) | Edwards Lifesciences, LLC | 2019-06-11 |
| Edwards Intuity Elite Valve System (P150036/S040) | Edwards Lifesciences, LLC | 2019-06-11 |
| LATITUDE Wave Communicator (P910077/S171) | Boston Scientific | 2019-06-10 |
| CRT-D Resynchronization Devices COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, (P010012/S501) | Boston Scientific Corp | 2019-06-10 |
| Subcutaneous ICD Devices: EMBLEM (P110042/S125) | Boston Scientific Corporation | 2019-06-10 |
| CRT-P Resynchronization Devices INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S183) | Guidant Corp. | 2019-06-10 |
| Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S075) | Boston Scientific | 2019-06-10 |
| Pacemaker Devices: ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA II supported (N970003/S238) | Boston Scientific Corp | 2019-06-10 |
| ICD Devices TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S436) | Boston Scientific | 2019-06-10 |
| Consulta CRT-P; Syncra CRT-P, Viva CRT-P (P010015/S397) | Medtronic, Inc. | 2019-06-06 |
| HeartWare Left Ventricular Assist System (P100047/S129) | Medtronic | 2019-06-06 |
| HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (P160029) | Philips Medical Systems, Inc. | 2019-06-06 |
| Adapta,Versa, Sensia IPG, Advisa DR IPG, DR MRI IPG, SR MRI IPG, Relia IPG, Sphera DR MRI IPG (P980035/S581) | Medtronic, Inc. | 2019-06-06 |
| PRO-Kinetic Energy Coronary Stent System, Papyrus (P160003/S008) | Biotronik AG | 2019-06-05 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro/Primo MRI DR/VR ICD, Protecta ICD, Prote (P980016/S708) | Medtronic Cardiac Rhythm Disease Management | 2019-06-05 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brav CRT-D, Brava Quad CRT-D, Claria MRi CRT-D, Claria MRI Quad CRT-D, Compia M (P010031/S668) | Medtronic Cardiac Rhythm Disease Management | 2019-06-05 |
| WATCHMAN Left Atrial Appendage Closure Device and Delivery System and WATCHMAN Access System (P130013/S030) | Boston Scientific Corp | 2019-06-04 |
| CareLink SmartSync Device Manager (P980035/S583) | Medtronic, Inc. | 2019-06-04 |
| CapSure Sense Leads (P830061/S169) | Medtronic Cardiac Rhythm Disease Management | 2019-06-04 |
| SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S088) | Edwards Lifesciences, LLC | 2019-06-04 |
| HeartMate 3 Left Ventricular Assist System (P160054/S017) | ABBOTT MEDICAL | 2019-06-04 |
| Arctic Front Advance Cardiac Cryoablation Catheters (P100010/S094) | Medtronic Cryocath, LP | 2019-06-04 |
| LOTUS Edge Valve System (P180029/S001) | Boston Scientific Corporation | 2019-06-04 |
| CareLink SmartSync Azure Astra Application (P890003/S406) | Medtronic, Inc. | 2019-06-04 |
| CapSureFix Novus Leads (P930039/S198) | Medtronic, Inc. | 2019-06-04 |
| AngioJet Ultra Thrombectomy System (P980037/S073) | Boston Scientific Corp | 2019-06-03 |
| Micra Transcatheter Pacing System (TPS) (P150033/S051) | Medtronic, Inc. | 2019-06-03 |
| MitraClip System (NTR and XTR) (P100009/S030) | ABBOTT MEDICAL | 2019-06-03 |
| Impella CP with SmartAssist (P140003/S052) | Abiomed, Inc. | 2019-06-02 |
| Avalus Bioprosthesis (P170006/S012) | Medtronic, Inc. | 2019-05-31 |
| Relay Thoracic Stent-Graft With Plus Delivery System (P110038/S022) | Bolton Medical, Inc. | 2019-05-31 |
| Evera MRI XT DR/VR SureScan, Evera MRI S DR/VR SureScan and Visia AF MRI VR SureScan and Implantable Cardioverter Defibr (P980016/S707) | Medtronic Cardiac Rhythm Disease Management | 2019-05-30 |
| Torque Wrench/Torque Driver (P910023/S416) | ABBOTT MEDICAL | 2019-05-30 |
| Wallstent Iliac Endoprostehsis with Unistep Plus Delivery System (P940019/S055) | Boston Scientific Scimed, Inc. | 2019-05-30 |
| Incraft AAA Stent Graft System (P150002/S002) | Cordis US Corporation | 2019-05-30 |
| Amplia MRI CRT-D SureScan, Amplia MRI Quad CRT-D SureScan, Compia MRI CRT-D SureScan, Compia MRI Quad CRT-D SureScan and (P010031/S667) | Medtronic Cardiac Rhythm Disease Management | 2019-05-30 |
| Wallstent Venous Endoprosthesis with UNISTEP Plus (P980033/S054) | Boston Scientific Corporation | 2019-05-30 |
| CapSureFix Novus MRI SureScan Lead (P930039/S197) | Medtronic, Inc. | 2019-05-30 |
| Medtronic Revo MRI SureScan IPG and Pacing System (P980035/S587) | Medtronic, Inc. | 2019-05-30 |
| Sprint Quattro Secure S MRI SureScan Lead and Sprint Quattro Secure MRI SureScan Lead (P920015/S229) | Medtronic, Inc. | 2019-05-30 |
| Wallstent TIPS Endoprosthesis with UNISTEP Plus (P930031/S064) | Boston Scientific Corp | 2019-05-30 |
| CapSureFix MRI Surescan Lead (P090013/S298) | Medtronic, Inc. | 2019-05-30 |
| Rotablator Rotational Angioplasty System Guidewire with wireClip Torquer (P900056/S178) | Boston Scientific Corp | 2019-05-30 |
| CapSure Sense MRI SureScan Lead (P830061/S168) | Medtronic Cardiac Rhythm Disease Management | 2019-05-30 |
| Express LD Iliac Premounted Stent System (P090003/S046) | Boston Scientific Corporation | 2019-05-30 |
| Attain Ability MRI SureScan Lead, Attain Ability Plus MRI SureScan Lead, Attain Ability Straight MRI SureScan Lead, Atta (P080006/S133) | Medtronic, Inc. | 2019-05-30 |
| Maestro Ablation Connection Box, IntellaNav XP and IntellaNav MiFi XP (P150005/S043) | Boston Scientific Corp | 2019-05-29 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Biopolar CRT-P and Serena Quadripolar (P010015/S406) | Medtronic, Inc. | 2019-05-29 |
| Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S DR/SR MRI IPG, and Azure XT DR/SR MRI IPG (P980035/S593) | Medtronic, Inc. | 2019-05-29 |
| SelectSecure Lead (P030036/S109) | Medtronic Cardiac Rhythm Disease Management | 2019-05-29 |
| Maestro Ablation Connection Box, IntellaNav OI (P020025/S118) | Boston Scientific | 2019-05-29 |
| Arctic Front Advance and Arctic Front Advance Pro Cardiac CryoAblation Catheters (P100010/S090) | Medtronic Cryocath, LP | 2019-05-29 |
| Tendril MRI Steroid Eluting Cardiac Leads (P140033/S045) | ABBOTT MEDICAL | 2019-05-29 |
| GORE Cardioform ASD Occluder (P050006/S071) | W. L. Gore & Associates, Inc. | 2019-05-28 |
| Manta Vascular Closure Device (P180025/S001) | Teleflex Medical, LLC | 2019-05-24 |
| Phylax ICD System (P980023/S092) | Biotronik, Inc. | 2019-05-24 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S022) | W. L. Gore & Associates, Inc. | 2019-05-24 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S068) | Boston Scientific | 2019-05-23 |
| Prostar XL Percutaneous Vascular Surgical System (P960043/S104) | Abbott Vascular, Inc. | 2019-05-23 |
| Angio-Seal Vascular Closure Devices (P930038/S095) | Terumo Medical Corporation | 2019-05-23 |
| Visi-Pro Balloon-Expandable Peripheral Stent System (P030045/S005) | Medtronic Vascular, Inc. | 2019-05-23 |
| VALITUDE CRT-P, VISIONIST CRT-P, VALITUDE X4 CRT-P, VISIONIST X4 CRT-P (P030005/S180) | Guidant Corp. | 2019-05-23 |
| Ingevity Leads (P150012/S077) | Boston Scientific | 2019-05-23 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P170003/S006) | Lutonix | 2019-05-23 |
| Protege RX Carotid Stent Systems and Protege GPS Peripheral Stent Systems (P060001/S027) | Medtronic Vascular, Inc. | 2019-05-23 |
| AMPLATZER PFO Occluder (P120021/S008) | ABBOTT MEDICAL | 2019-05-23 |
| EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding peripheral Stent with Entrust Delivery Syst (P110023/S026) | Medtronic Vascular, Inc. | 2019-05-23 |