| IntellaNav OI and IntellaNav MiFi OI Ablation Catheters (P150005/S042) | Boston Scientific Corp | 2019-04-18 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD (P140003/S044) | Abiomed, Inc. | 2019-04-17 |
| Impella RP System (P170011/S009) | Abiomed, Inc. | 2019-04-17 |
| Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System (P940019/S054) | Boston Scientific Scimed, Inc. | 2019-04-17 |
| GORE VIABAHN Endoprosthesis (P040037/S131) | W. L. Gore & Associates, Inc. | 2019-04-17 |
| Wallstent Venous Endoprosthesis with UNISTEP Plus (P980033/S053) | Boston Scientific Corporation | 2019-04-17 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S070) | W. L. Gore & Associates, Inc. | 2019-04-17 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems (P140003/S047) | Abiomed, Inc. | 2019-04-17 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S068) | Syncardia Systems, LLC | 2019-04-17 |
| Rotablator Rotational Angioplasty System Guidewire with wireClip Torquer (P900056/S177) | Boston Scientific Corp | 2019-04-17 |
| Wallstent TIPS Endoprosthesis with UNISTEP Plus (P930031/S063) | Boston Scientific Corp | 2019-04-17 |
| Express LD Iliac Premounted Stent System (P090003/S045) | Boston Scientific Corporation | 2019-04-17 |
| Protego TD, SD 75/18, 65/18, 65/16 and SD 60/16 Protego T 65, and S 75, 65, 60 Plexa S 60, PLexa SD 60/16, Plexa ProMRI (P980023/S091) | Biotronik, Inc. | 2019-04-16 |
| Amplia, Amplia Brava ,Brava Quad, Claria Claria Quard, Compia, Consulta, Protecta, Viva MRI XT S CRT-D (P010031/S663) | Medtronic Cardiac Rhythm Disease Management | 2019-04-16 |
| Blazere II Ablation Catheters, Blazer II XP Ablation Catheters, Blazer Prime Ablation Catheters (P020025/S117) | Boston Scientific | 2019-04-16 |
| Evera, Mirro, Primo, Protecta, Secura, Visia, S DR, VR XT DF1 MRI ICD (P980016/S703) | Medtronic Cardiac Rhythm Disease Management | 2019-04-16 |
| Consulta; Percepta Bipolar, Quadripolar; Serena Bipolar, Quadripolar; Syncra; Viva CRT-P (P010015/S401) | Medtronic, Inc. | 2019-04-16 |
| Sentus ProMRI OTW QP S-75, 85, 95, L-75, 85, 95, Sentus ProMRI OTW QP S-75/49, 85/49, 95/49, L-75/49, 85/49, 9/49 and Se (P070008/S102) | Biotronik, Inc. | 2019-04-16 |
| Micra TPS (P150033/S053) | Medtronic, Inc. | 2019-04-16 |
| Adapta, Versa, Sensia, Advisa, Astra, Attesta, Azure, Relia, Sphera, DR S XT SR MRI IPG (P980035/S585) | Medtronic, Inc. | 2019-04-16 |
| IntellaTip MiFi Xp Ablation Catheters, IntellaNsv MiFi XP Ablation Catheters and IntellaNav ST Ablation Catheters (P920047/S114) | Boston Scientific Corp | 2019-04-16 |
| CareLink SmartSync Device Manager Programmer (P890003/S409) | Medtronic, Inc. | 2019-04-16 |
| Permanent Defibrillator Electrodes: Protego SD, Protego TD, Protego S and Protego T (P980023/S090) | Biotronik, Inc. | 2019-04-15 |
| Siello S45, S53, S60 and Solia S45, S53, S60 (P950037/S199) | Biotronik, Inc. | 2019-04-15 |
| Ilesto 7 VR-T, Iforia 7 VR-T, Ilesto 5 VR-T, Iforia 5 VR-T, Inventra 7 VR-T, Iperia 7 VR-T, Itrevia 7 VR-T, Iperia 5 VR- (P050023/S128) | Biotronik, Inc. | 2019-04-15 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S032) | Medinol, Ltd. | 2019-04-12 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S015) | Medinol, Ltd. | 2019-04-12 |
| Biosense Webster NaviStar Thermocool Catheter (P030031/S091) | Biosense Webster, Inc. | 2019-04-12 |
| Impella RP (P170011/S010) | Abiomed, Inc. | 2019-04-12 |
| Electrophysiology Cable, Therapy Ablation Catheter (P040014/S036) | Irvine Biomedical, Inc. | 2019-04-11 |
| Therapy Cool Flex, Path Duo, Safire Duo, MediGuide Enabled Ablation Catheter; Mediguide Enabled (P110016/S060) | ABBOTT MEDICAL | 2019-04-11 |
| Electrophysiology Cable; SE-Safire TX, Catheter Extension Cable; Therapy 8mm, Thermistor, Dual 8, Safire TX Ablation Cat (P040042/S042) | Irvine Biomedical,Inc.(Ibi) | 2019-04-11 |
| Tack Endovascular System (6F) (P180034) | Philips Image Guided Therapy Corporation | 2019-04-11 |
| Therapy Cool Path Ablation Catheter (P060019/S045) | Irvine Biomedical, Inc. | 2019-04-11 |
| Amplia MRI Quad CRT-D SureScan, Compia MRI Quad CRT-D SureScan, Claria MRI Quad CRT-D SureScan and Implantable Defibrill (P010031/S654) | Medtronic Cardiac Rhythm Disease Management | 2019-04-10 |
| Sprint Quattro Secure S MRI SureScan Lead, Sprint Quattro Secure MRI SureScaan Lead and Sprint Quattro MRI SureScan Lead (P920015/S222) | Medtronic, Inc. | 2019-04-10 |
| CapSureFix MRI SureScan Lead (P090013/S293) | Medtronic, Inc. | 2019-04-10 |
| SelectSecure MRI SureScan Lead (P030036/S106) | Medtronic Cardiac Rhythm Disease Management | 2019-04-10 |
| Diamondback 360 Coronary Orbital Atherectomy Device (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C (P130005/S025) | Cardiovascular Systems, Inc. | 2019-04-10 |
| Percepta Quad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan and Implantable Pulse G (P010015/S385) | Medtronic, Inc. | 2019-04-10 |
| CapSure Sense MRI SureScan Lead (P830061/S165) | Medtronic Cardiac Rhythm Disease Management | 2019-04-10 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S043) | St Jude Medical | 2019-04-10 |
| CapSureFix Novus MRI SureScan Lead (P930039/S194) | Medtronic, Inc. | 2019-04-10 |
| Attain Stability Quad MRI SureScan Lead (P080006/S129) | Medtronic, Inc. | 2019-04-10 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S016) | W. L. Gore & Associates, Inc. | 2019-04-09 |
| Accessory Kit (P940031/S078) | Boston Scientific | 2019-04-08 |
| ACUITY X4 Straight 86CM ,95CM, ACUITY X4 Spiral S 86CM, 95CM, ACUITY X4 Spiral L 86CM, L95CM, Accessory Suture Sleeves S (P010012/S500) | Boston Scientific Corp | 2019-04-08 |
| HeartLight Endoscopic Ablation System (P150026/S005) | Cardiofocus, Inc. | 2019-04-08 |
| Accessory Stylet TAPER .014 45CM, .014 52CM, .014 58CM, .016 45CM, .016 52CM, and .016 58CM, Accessory Stylet TAPER .013 (P960004/S089) | Boston Scientific | 2019-04-08 |
| Accessory Wrench Socket Cap Brady/Tachy (N970003/S237) | Boston Scientific Corp | 2019-04-08 |
| Accessory Wrench (P930035/S030) | Boston Scientific | 2019-04-08 |
| Accessory Stylet STR 0.013 45CM, Accessory Stylet STR 0.013 52CM,Accessory Stylet STR 0.013 59CM, Accessory Stylet LTPR (P150012/S074) | Boston Scientific | 2019-04-08 |
| LV Lead Quadpole Connector IS4, Accessory Kit Lead Cap, Accessory Stylet TAPER FIX SOFT 64CM, 70CM, and 100CM, Accessory (P910073/S154) | Boston Scientific | 2019-04-08 |
| Accessory Hex Wrench (P840068/S054) | Boston Scientific | 2019-04-08 |
| Emblem S-ICD Electrode 45cm (P110042/S124) | Boston Scientific Corporation | 2019-04-08 |
| ZOOM LATTITUDE Programmer System Accessory Kit, Adapter Power RF COmmunicator, Accessory Kit Lead Cap, Accessory Wand T (P910077/S170) | Boston Scientific | 2019-04-08 |
| Accessory Medical Adhesive, Accessory Mineral Oil, Accessory Vein Pick, Accessory Kit Lead Cap, Accessory Stylet TAPER 0 (P830060/S083) | Boston Scientific | 2019-04-08 |
| Accessory Kit Suture Sleeve Stabilizer and Accessory Terminal Pin Fixation Tool (P960006/S049) | Boston Scientific | 2019-04-08 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprothesis (P150048/S032) | Edwards Lifesciences, LLC | 2019-04-04 |
| Cardiac Resynchronization Therapy Pacemakers (CRT-P) Percepta Bipolar CRT-P, Percepta Quadtripolar CRT-P; Serena Bipolar (P010015/S396) | Medtronic, Inc. | 2019-04-04 |
| CardioMEMS HF System (P100045/S036) | ABBOTT MEDICAL | 2019-04-04 |
| Implantable Pulse Generators (IPG) Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG; Azu (P980035/S580) | Medtronic, Inc. | 2019-04-04 |
| Arctic Fron Advance and Arctic Front Advance Pro Cardiac CryoAblation Catheters (P100010/S089) | Medtronic Cryocath, LP | 2019-04-03 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S020) | Boston Scientific Corp | 2019-04-02 |
| Vistag Surpoint External Process Unit (EPU) (P030031/S092) | Biosense Webster, Inc. | 2019-04-02 |
| TherOx Downstream System (P170027) | Zoll Circulation, Inc. | 2019-04-02 |
| WATCHMAN Left Atrial Appendage Closure Device and Delivery System (P130013/S028) | Boston Scientific Corp | 2019-04-01 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S043) | Boston Scientific Corporation | 2019-03-29 |
| Angio Seal Vascular Closure Devices (P930038/S093) | Terumo Medical Corporation | 2019-03-29 |
| LifeVest Wearable Defibrillator (P010030/S116) | Zoll Manufacturing Corporation | 2019-03-27 |
| CPR Stat-Padz Electrode and CPR-D Padz Electrode (P160015/S002) | ZOLL Medical Corporation | 2019-03-27 |
| Percepta Bipolar CRT-P, Quadripolar CRT-P, Serena Bipolar CRT-P, Quadripolar CRT-P, Solara Bipolar CRT-P, Quadripolar CR (P010015/S391) | Medtronic, Inc. | 2019-03-27 |
| Astra S DR MRI IPG, SR MRI IPG, Astra XT DR MRI IPG, SR MRI IPG, Azure S DR MRI IPG, SR MRI IPG, Azure XT DR MRI IPG, SR (P980035/S576) | Medtronic, Inc. | 2019-03-27 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) plus generator (PG) devices (P110042/S122) | Boston Scientific Corporation | 2019-03-27 |
| Myocardial Pacing Lead (P120017/S017) | Medtronic, Inc. | 2019-03-26 |
| Anchoring Sleeve Kit and SelectSecure Lead (P030036/S108) | Medtronic Cardiac Rhythm Disease Management | 2019-03-26 |
| CapSure Epicardial Pacing Lead (P950024/S084) | Medtronic, Inc. | 2019-03-26 |
| Amplia MRI CRT-D, MRI Quad CRT-D; Brava CRT-D, Quad CRT-D; Claria MRI CRT-D, MRI Quad CRT-D; Compia MRI CRT-D, MRI Quad (P010031/S659) | Medtronic Cardiac Rhythm Disease Management | 2019-03-26 |
| Attain Bipolar OTW Lead and Attain OTW LV Lead (P010015/S394) | Medtronic, Inc. | 2019-03-26 |
| CapSure VDD 2 Lead, Service Kit-Pacemaker Repair Kit and Vitatron Brilliant S+ VDD Lead (P890003/S405) | Medtronic, Inc. | 2019-03-26 |
| HeartWare Ventricular Assist System (P100047/S136) | Medtronic | 2019-03-26 |
| Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (P010015/S392) | Medtronic, Inc. | 2019-03-26 |
| ThermoCool SmartTouch SF Bi-Directional Navigation Catheter; ThermoCool SmartTouch SF Uni-Directional Navigation Cathete (P040036/S064) | Biosense Webster, Inc. | 2019-03-26 |
| CapSureFix MRI Lead (P090013/S296) | Medtronic, Inc. | 2019-03-26 |
| Adapta, Versa, Sensia IPG; Advisa DR IPG, DR MRI IPG, SR MRI IPG; Astra S DR MRI IPG, S SR MRI IPG, XT DR MRI IPG, XT SR (P980035/S577) | Medtronic, Inc. | 2019-03-26 |
| HeartWare Left Ventricular Assist Device System (P100047/S137) | Medtronic | 2019-03-26 |
| Evera: MRI DF-1 ICD, MRI ICD, S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, MRI VR ICD; Primo MRI DR ICD, (P980016/S699) | Medtronic Cardiac Rhythm Disease Management | 2019-03-26 |
| Adhesive, CapSure Sense Lead, CapSure SP Novvus Lead Stylet Kit and Vitatron Crystalline Lead (P830061/S167) | Medtronic Cardiac Rhythm Disease Management | 2019-03-26 |
| INCRAFT AAA Stent Graft System (P150002/S001) | Cordis US Corporation | 2019-03-26 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, IS-1 Connector Port Pin Plug, Lead Adaptor, Sprint Quattro Lead, H (P920015/S226) | Medtronic, Inc. | 2019-03-26 |
| Attain Ability Lead and Attain Performa Lead (P080006/S131) | Medtronic, Inc. | 2019-03-26 |
| CardioMEMS HF System (P100045/S039) | ABBOTT MEDICAL | 2019-03-26 |
| CapSureFIx Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S196) | Medtronic, Inc. | 2019-03-26 |
| ThermoCool SmartTouch Bi-Directional Navigation Catheter; ThermoCool SmartTouch Uni-Directional Navigation Catheter (P030031/S094) | Biosense Webster, Inc. | 2019-03-26 |
| Transvene CS/SVS Lead (P980050/S121) | Medtronic, Inc. | 2019-03-26 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Stylet Kit and Vitatron Impulse II Lead (P850089/S140) | Medtronic Cardiac Rhythm Disease Management | 2019-03-26 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S032) | Cook Ireland, Ltd. | 2019-03-26 |
| EXOSEAL Vascular Closure Device (P100013/S018) | Cordis US Corporation | 2019-03-26 |
| Attain StarFix Lead (P060039/S093) | Medtronic, Inc. | 2019-03-26 |
| ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve (P900061/S152) | Medtronic Cardiac Rhythm Disease Management | 2019-03-26 |