| Sapien XT Transcatheter Heart Valve and Accessories (P130009/S100) | Edwards Lifesciences, LLC | 2019-09-17 |
| GORE CARDIOFORM Septal Occluder (GSO) (P050006/S077) | W. L. Gore & Associates, Inc. | 2019-09-17 |
| Sapien 3 Transcatheter Heart Valve and Accessories (P140031/S094) | Edwards Lifesciences, LLC | 2019-09-17 |
| CardioMessenger Smart 3G (P050023/S135) | Biotronik, Inc. | 2019-09-16 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S028) | Medtronic Vascular | 2019-09-16 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S100) | Medtronic Vascular | 2019-09-16 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S034) | Cook Ireland, Ltd. | 2019-09-13 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S053) | Boston Scientific Corporation | 2019-09-13 |
| Lutonix Drug Coated Balloon PTA Catheter (P130024/S029) | Lutonix | 2019-09-13 |
| Innova Self-Expanding Stent System (P140028/S042) | Boston Scientific Corporation | 2019-09-13 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Ballon (P160049/S007) | The Spectranetics Corp. | 2019-09-13 |
| CapSureFix Novus Lead (P930039/S204) | Medtronic, Inc. | 2019-09-13 |
| In.Pact Admiral Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S047) | Medtronic, Inc. | 2019-09-13 |
| Epic Vascular Self-Expanding Stent System (P110035/S052) | Boston Scientific Corp | 2019-09-13 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S011) | Boston Scientific Corp | 2019-09-13 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S014) | Boston Scientific Corp | 2019-09-13 |
| Evera MRI DF-1, MRI, S DR, S VR, XT DR, XT VR, Mirro MRI DR, MRI VR, Primo MRI DR, MRI VR, Visia AF MRI DF1, AF MRI VR, (P980016/S718) | Medtronic Cardiac Rhythm Disease Management | 2019-09-13 |
| Amplia MRI, MRI Quad, Brava, Brava Quad, Claria MRI, MRI Quad, Compia MRI, MRI Quad, and Viva Quad S, Quad XT, S, XT CRT (P010031/S679) | Medtronic Cardiac Rhythm Disease Management | 2019-09-13 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) pulse generator (PG) high voltage (HV) capacitor stack (P110042/S127) | Boston Scientific Corporation | 2019-09-13 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S023) | ABBOTT MEDICAL | 2019-09-12 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S075) | ABBOTT MEDICAL | 2019-09-12 |
| EnVeo R and PRO Delivery Catheter System (P130021/S063) | Medtronic, Inc. | 2019-09-11 |
| MitraClip NTR, XTR and G4 Clip Delivery System (P100009/S035) | ABBOTT MEDICAL | 2019-09-11 |
| Xience Xpedition Everolimus Eluting Coronary Stent System and Xience Alpine Everolimus Eluting Coronary Stent System (P110019/S107) | Abbott Vascular | 2019-09-10 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S007) | Bard Peripheral Vascular, Inc. | 2019-09-09 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S010) | Boston Scientific Corp | 2019-09-06 |
| Innova Vascular Self-Expanding Stent System (P140028/S043) | Boston Scientific Corporation | 2019-09-06 |
| HeartWare Left Ventricular Assist Device System (P100047/S145) | Medtronic | 2019-09-06 |
| BioGlue Surgical Adhesive (P010003/S035) | Cryolife, Inc. | 2019-09-05 |
| Quadra Assura, Unify, Unify Assura, and Unify Quadra CRT-D Devices (P030054/S370) | ABBOTT MEDICAL | 2019-09-04 |
| ENROUTE Transcarotid Stent System (P140026/S013) | Boston Scientific Corporation | 2019-09-04 |
| Ilivia Neo 7 DR-T and Intica Neo 7 and 5 DR-T (P000009/S080) | Biotronik, Inc. | 2019-09-04 |
| Ilivia Neo 7 VR-T, Intica Neo 7 and 5 VR-T, Ilivia Neo 7 VR-T DX, and Intica Neo 7 and 5 VR-T DX (P980023/S093) | Biotronik, Inc. | 2019-09-04 |
| Ilivia Neo 7 HF -T, Intica Neo 7 and 5 HF -T, Ilivia Neo 7 HF -T QP, and Intica Neo 7 and 5 HF -T QP (P050023/S133) | Biotronik, Inc. | 2019-09-04 |
| Ellipse, Fortify, Fortify Assura, and Quadra Assura MP ICD Devices (P910023/S418) | ABBOTT MEDICAL | 2019-09-04 |
| LifeVest Wearable Defibrillator (P010030/S125) | Zoll Manufacturing Corporation | 2019-09-03 |
| Advisa DR MRI and Advisa DR/DR MRI IPG (P980035/S604) | Medtronic, Inc. | 2019-08-30 |
| Protecta ICD, Protecta VR, XT ICD and Secura ICD, Secura DR ICD (P980016/S717) | Medtronic Cardiac Rhythm Disease Management | 2019-08-30 |
| Consulta, Protecta and Protecta XT CRT-D (P010031/S678) | Medtronic Cardiac Rhythm Disease Management | 2019-08-30 |
| Consulta, Synca and Viva CRT-P (P010015/S418) | Medtronic, Inc. | 2019-08-30 |
| Tendril MRI Steroid Eluting Cardiac Leads (P140033/S046) | ABBOTT MEDICAL | 2019-08-30 |
| MitraClip NT, NTR, XTR, G4 Clip Delivery System (P100009/S034) | ABBOTT MEDICAL | 2019-08-30 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S003) | Biotronik AG | 2019-08-29 |
| Therapy Dual-8, Therapy 8mm Thermistor, Safire TX Ablation Catheter (P040042/S043) | Irvine Biomedical,Inc.(Ibi) | 2019-08-28 |
| Therapy Ablation , Therapy 4mm Thermistor Ablation Catheter (P040014/S037) | Irvine Biomedical, Inc. | 2019-08-28 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S603) | Medtronic, Inc. | 2019-08-27 |
| Medtronic Attain Ability Plus Left Ventricular Lead (P080006/S139) | Medtronic, Inc. | 2019-08-27 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S417) | Medtronic, Inc. | 2019-08-27 |
| CELT ACD Vascular Closure Device (P150006/S004) | Vasorum, Ltd. | 2019-08-26 |
| HeartMate 3 Left Ventricular Assist System (P160054/S020) | ABBOTT MEDICAL | 2019-08-25 |
| Percepta/Percepta Quad CRT-P MRI SureScan devices (P010015/S411) | Medtronic, Inc. | 2019-08-23 |
| HeartWare Ventricular Assist System (P100047/S143) | Medtronic | 2019-08-23 |
| Maestro 4000 Controller Firmware (P020025/S121) | Boston Scientific | 2019-08-23 |
| Maestro 4000 Controller Firmware (P920047/S117) | Boston Scientific Corp | 2019-08-23 |
| CoreValve Evolut R System and CoreValve Evolut PRO System (P130021/S062) | Medtronic, Inc. | 2019-08-23 |
| Claria MRI/Claria MRI Quad CRT-D SureScan devices (P010031/S672) | Medtronic Cardiac Rhythm Disease Management | 2019-08-23 |
| Blazer OI, IntellaNav OI, IntellaTip Mifi OI, and IntellaNav Mifi OI Cardiac Ablation Percutaneous Catheter (P150005/S047) | Boston Scientific Corp | 2019-08-23 |
| Maestro 4000 Controller Firmware (P980003/S090) | Boston Scientific Corp | 2019-08-23 |
| AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024/S057) | ABBOTT MEDICAL | 2019-08-22 |
| AMPLATZER PFO OCCLUDER (P120021/S012) | ABBOTT MEDICAL | 2019-08-22 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S037) | ABBOTT MEDICAL | 2019-08-22 |
| THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039/S067) | ABBOTT MEDICAL | 2019-08-22 |
| TACTICATH QUARTZ SET (P130026/S048) | St Jude Medical | 2019-08-22 |
| AngioSculpt PTCA Scoring Balloon Catheter (P050018/S027) | Spectranetics Corp. | 2019-08-22 |
| AED Pro Device (P160022/S012) | ZOLL Medical Corporation | 2019-08-22 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S407) | Medtronic, Inc. | 2019-08-22 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S595) | Medtronic, Inc. | 2019-08-22 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S063) | ABBOTT MEDICAL | 2019-08-22 |
| LIVEWIRE(R) CARDIAC ABLATION SYSTEM (P960016/S079) | St Jude Medical | 2019-08-22 |
| PALMAZ Balloon Expandable Stent (P890017/S020) | Cordis US Corporation | 2019-08-21 |
| ATS 3F AORTIC BIOPROSTHESIS MODEL 1000 (P060025/S002) | Medtronic, Inc. | 2019-08-21 |
| SAPIEN 3 Transcatheter Heart Valve and Accessories (P140031/S091) | Edwards Lifesciences, LLC | 2019-08-21 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S106) | Abbott Vascular, Inc. | 2019-08-21 |
| LOTUS Edge Valve System (P180029/S010) | Boston Scientific Corporation | 2019-08-21 |
| Vitatron Software application (P890003/S412) | Medtronic, Inc. | 2019-08-20 |
| Powerheart® G3, G3 Plus and G5 AEDs (P160033/S004) | ZOLL Medical Corporation | 2019-08-20 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S052) | Boston Scientific Corporation | 2019-08-20 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System Monorail (MR) and Over-The-Wire (OTW) and Prom (P110010/S168) | Boston Scientific Corp | 2019-08-20 |
| Powerheart® G3 Pro AED (P160034/S001) | ZOLL Medical Corporation | 2019-08-20 |
| Adapta, Versa, Sensia IPG, Software application, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, (P980035/S594) | Medtronic, Inc. | 2019-08-20 |
| CoreValve Evolut R System and CoreValve Evolut PRO System (P130021/S061) | Medtronic, Inc. | 2019-08-19 |
| Fortify and Fortify Assura ICD Devices (P910023/S417) | ABBOTT MEDICAL | 2019-08-19 |
| Unify, Unify Quadra/Assura and Quadra Assura/MP (P030054/S369) | ABBOTT MEDICAL | 2019-08-19 |
| SAPIEN 3 Ultra transcatheter heart valve (P140031/S085) | Edwards Lifesciences, LLC | 2019-08-16 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S020) | Medinol, Ltd. | 2019-08-16 |
| Cool Point Irrigation Pump (P060019/S043) | Irvine Biomedical, Inc. | 2019-08-16 |
| AFX Endovascular AAA System (P040002/S063) | Endologix, LLC | 2019-08-16 |
| BAROSTIM NEO® System (P180050) | Cvrx, Inc. | 2019-08-16 |
| Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System (P130021/S058) | Medtronic, Inc. | 2019-08-16 |
| LOTUS Edge Valve System (P180029/S009) | Boston Scientific Corporation | 2019-08-15 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S073) | Syncardia Systems, LLC | 2019-08-15 |
| SAPIEN 3 Transcatheter Heart Valve and Accessories (P140031/S090) | Edwards Lifesciences, LLC | 2019-08-15 |
| INCRAFT(R) AAA Stent Graft System (P150002/S006) | Cordis US Corporation | 2019-08-15 |
| On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study (P000037/S054) | On-X Life Technologies, Inc. | 2019-08-15 |
| Astron Pulsar/Pulsar-18 Stent Systems (P160025/S008) | Biotronik AG | 2019-08-14 |
| BioGlue Surgical Adhesive (P010003/S036) | Cryolife, Inc. | 2019-08-14 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S010) | Biotronik AG | 2019-08-14 |
| OPTIMIZER Smart System (P180036/S002) | Impulse Dynamics (Usa), Inc. | 2019-08-13 |
| Resolute Onyx Coronary Stent Systems (P160043/S026) | Medtronic Vascular | 2019-08-12 |
| VenaSeal Closure System (P140018/S016) | Medtronic Vascular, Inc. | 2019-08-12 |