| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, (P980035/S663) | Medtronic, Inc. | 2021-02-09 |
| Attain Ability Lead (P080006/S157) | Medtronic, Inc. | 2021-02-09 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S458) | Medtronic, Inc. | 2021-02-09 |
| 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/S724) | Medtronic Cardiac Rhythm Disease Management | 2021-02-09 |
| Attain Ability Straight Left Ventricular Lead (P080006/S156) | Medtronic, Inc. | 2021-02-09 |
| Attain Bipolar OTW Lead (P010015/S465) | Medtronic, Inc. | 2021-02-09 |
| Micra AV TPS, Micra TPS (P150033/S088) | Medtronic, Inc. | 2021-02-09 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M (P980016/S764) | Medtronic Cardiac Rhythm Disease Management | 2021-02-09 |
| MyCareLink Patient Monitor (P890003/S438) | Medtronic, Inc. | 2021-02-09 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S192) | Medtronic Cardiac Rhythm Disease Management | 2021-02-09 |
| Rotablator or ROTAPRO Rotational Atherectomy System (P900056/S183) | Boston Scientific Corp | 2021-02-05 |
| PROMUS Element Plus Everolimus-Eluting Coronary Stent System, Promus PREMIER Everolimus-Eluting Coronary Stent System, P (P110010/S187) | Boston Scientific Corp | 2021-02-05 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S042) | Medtronic Vascular | 2021-02-04 |
| IN.PACT AV Paclitaxel-Coated PTA Balloon Catheter (P190008/S009) | Medtronic Vascular, Inc. | 2021-02-04 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S106) | Medtronic Vascular | 2021-02-04 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S055) | Medtronic, Inc. | 2021-02-04 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D (P010031/S729) | Medtronic Cardiac Rhythm Disease Management | 2021-02-03 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D (P980016/S767) | Medtronic Cardiac Rhythm Disease Management | 2021-02-03 |
| Powerheart® G5 AED (P160033/S005) | ZOLL Medical Corporation | 2021-02-02 |
| Contak Renewal (P030005/S205) | Guidant Corp. | 2021-02-02 |
| Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software (N970003/S259) | Boston Scientific Corp | 2021-02-02 |
| LATITUDE Programming System (P910077/S182) | Boston Scientific | 2021-02-02 |
| AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) (P190013) | Aed Battery Exchange, LLC | 2021-02-02 |
| Thermocool SF NAV, Celsius Thermocool, EZ Steer Thermocool, EZ Steer Thermocool Bi-Directional, and Navistar Thermocool (P030031/S112) | Biosense Webster, Inc. | 2021-02-02 |
| Celsius Fluter, NavistarDS Diagnostic, Celsius DS, EZ Steer Nav DS (P010068/S061) | Biosense Webster, Inc. | 2021-02-02 |
| Navistar EP, EZ Steer Nav Bi-Directional (P990025/S061) | Biosense Webster, Inc. | 2021-02-02 |
| Subcutaneous Implantable Defibrillator(S-ICD) System (P110042/S150) | Boston Scientific Corporation | 2021-02-02 |
| Ventak AV AICD, Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defibrillator Syste (P960040/S460) | Boston Scientific | 2021-02-02 |
| Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S529) | Boston Scientific Corp | 2021-02-02 |
| Imageready MR Conditional Pacing System and Ingevity PACE/SENSE Lead (P150012/S104) | Boston Scientific | 2021-02-02 |
| Celsius, Celsius Flutter, EZ Steer (P950005/S076) | Biosense Webster, Inc. | 2021-02-02 |
| EZ Steer Thermocool, EZ Steer Thermocool Bi-Directional, Navistar Thermocool (P040036/S077) | Biosense Webster, Inc. | 2021-02-02 |
| Gore Excluder Conformable AAA Endoprosthesis (P200030/S001) | W. L. Gore and Associates, Inc. | 2021-02-01 |
| LifeVest Wearable Defibrillator (P010030/S144) | Zoll Manufacturing Corporation | 2021-01-29 |
| NaviStar THERMOCOOL Deflectable Diagnostic/Ablation Catheter (P030031/S102) | Biosense Webster, Inc. | 2021-01-28 |
| Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, and Solara Quadripolar dual (P010015/S456) | Medtronic, Inc. | 2021-01-28 |
| Astra S DR MRI, Astra S SR MRI, Astra XT DR MRI, Astra XT SR MRI, Azure S DR MRI, Azure S SR MRI, Azure XT DR MRI, Azure (P980035/S659) | Medtronic, Inc. | 2021-01-28 |
| DiamondTemp Ablation System (P200028) | Medtronic, Inc. | 2021-01-28 |
| EZ Steer ThermoCool Nav Deflectable Diagnostic/Ablation Catheter (P040036/S070) | Biosense Webster, Inc. | 2021-01-28 |
| SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S099) | Edwards Lifesciences, LLC | 2021-01-27 |
| Preveleak Surgical Sealant (P100030/S013) | Baxter Healthcare Corporation | 2021-01-26 |
| GORE Cardioform Septal Occluder and GORE Cardioform ASD Occluder (P050006/S089) | W. L. Gore & Associates, Inc. | 2021-01-26 |
| GORE® VIATORR® TIPS Endoprosthesis (P040027/S082) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S141) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| ThermoCool SmartTouch Catheters (P030031/S111) | Biosense Webster, Inc. | 2021-01-22 |
| GORE® EXCLUDER® AAA Endoprosthesis and GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004/S177) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S054) | Boston Scientific Corporation | 2021-01-22 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S080) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S027) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| ThermoCool SmartTouch SF Catheters (P040036/S076) | Biosense Webster, Inc. | 2021-01-22 |
| GORE® CARDIOFORM Septa! Occluder and GORE® CARDIOFORM ASD Occluder (P050006/S088) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| GORE® TAG® Thoracic Endoprosthesis and GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S121) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| Micra AV TPS, Micra TPS (P150033/S090) | Medtronic, Inc. | 2021-01-21 |
| Adaptor Assembly Cable, ECG Cable, Patient Cable, and Analyzer Cable (P890003/S437) | Medtronic, Inc. | 2021-01-21 |
| Patient Cable and Surgical Cable (P820003/S138) | Medtronic Cardiac Rhythm Disease Management | 2021-01-21 |
| TMR Holmium Laser System (P970029/S038) | Cryolife, Inc. | 2021-01-21 |
| VenaSeal Closure System (P140018/S021) | Medtronic Vascular, Inc. | 2021-01-21 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System (P130021/S082) | Medtronic, Inc. | 2021-01-15 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) (P130005/S032) | Cardiovascular Systems, Inc. | 2021-01-14 |
| FINELINE II Sterox, Endocardial Pacing Lead, Passive Fixation (P960004/S092) | Boston Scientific | 2021-01-13 |
| EASYTRAK® 2 1S-1 Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead, EASYTRAK® 3 IS-1 Coronary Venous Steroid-Eluti (P010012/S531) | Boston Scientific Corp | 2021-01-13 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S019) | Berlin Heart, Inc. | 2021-01-13 |
| INGEVITY non-MRI Lead Passive Fixation, Preformed Atrial J, INGEVITY non-MRI Lead Passive Fixation, Ventricular, INGEV (P150012/S106) | Boston Scientific | 2021-01-13 |
| ACUITY Steerable Heart Failure Lead (P050046/S030) | Guidant Corp. | 2021-01-13 |
| EMBLEM S-ICD Subcutaneous Electrode (P110042/S152) | Boston Scientific Corporation | 2021-01-13 |
| Endotak Lead System (P910073/S159) | Boston Scientific | 2021-01-13 |
| FLEXTEND® Bipolar, Steroid Eluting, Extendable/Retractable Pacing Lead (P960006/S050) | Boston Scientific | 2021-01-13 |
| Philips HeartStart FR3 Defibrillator (P160028/S002) | Philips Medical Systems, Inc. | 2021-01-11 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S066) | St Jude Medical | 2021-01-10 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S063) | St Jude Medical | 2021-01-10 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S033) | ABBOTT MEDICAL | 2021-01-07 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S005) | Boston Scientific Corporation | 2021-01-07 |
| Evolut PRO+ TAV of the Evolut PRO+ System, Evolut PRO TAV of the Evolut PRO System and Evolut R TAV of the Evolut R Syst (P130021/S084) | Medtronic, Inc. | 2021-01-06 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S072) | ABBOTT MEDICAL | 2021-01-06 |
| X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower (P160022/S025) | ZOLL Medical Corporation | 2021-01-05 |
| R Series Device (P160022/S024) | ZOLL Medical Corporation | 2021-01-05 |
| Freestyle Bioprosthesis (P970031/S068) | Medtronic, Inc. | 2021-01-05 |
| Hancock Valved Conduit (P870078/S048) | Medtronic, Inc. | 2021-01-05 |
| Hancock II Bioprosthesis (P980043/S074) | Medtronic, Inc. | 2021-01-05 |
| Mosaic Bioprosthesis (P990064/S083) | Medtronic, Inc. | 2021-01-05 |
| Hancock Modified Orifice Valved Conduit (P790007/S063) | Medtronic Heart Valves | 2021-01-05 |
| Protege GPS Self-Expanding Peripheral Stent System (P060001/S031) | Medtronic Vascular, Inc. | 2021-01-04 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S031) | Medtronic Vascular, Inc. | 2021-01-04 |
| ZOLL Stat-padz II Electrodes and ZOLL Pedi-padz II Electrodes (P160015/S008) | ZOLL Medical Corporation | 2020-12-30 |
| OPTIMIZER Smart System (2-Lead configuration) (P180036/S006) | Impulse Dynamics (Usa), Inc. | 2020-12-30 |
| ZOLL CPR Uni-padz (P160015/S009) | ZOLL Medical Corporation | 2020-12-30 |
| RF Conductr, RF Contactr, RF Marinr, RF Marinr Unipolar, and RF Enhancr II (P930029/S069) | Medtronic, Inc. | 2020-12-23 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S037) | Cook Ireland, Ltd. | 2020-12-22 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (P130024/S037) | Lutonix | 2020-12-22 |
| CardioMEMS HF System (P100045/S046) | ABBOTT MEDICAL | 2020-12-22 |
| CapSureFix MRI Lead (P090013/S313) | Medtronic, Inc. | 2020-12-22 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S667) | Medtronic, Inc. | 2020-12-22 |
| AngelMed Guardian System (P150009/S004) | Avertix Medical, Inc. | 2020-12-22 |
| Spectranetics CVX-300 Excimer Laser System (P910001/S111) | Spectranetics Corp. | 2020-12-22 |
| CapSureFix Novus Lead (P930039/S220) | Medtronic, Inc. | 2020-12-22 |
| CapSure Sense Lead (P830061/S189) | Medtronic Cardiac Rhythm Disease Management | 2020-12-22 |
| Gore Excluder Conformable AAA Endoprosthesis (CEXC) (P200030) | W. L. Gore and Associates, Inc. | 2020-12-22 |
| Zoll AED 3 (P160015/S007) | ZOLL Medical Corporation | 2020-12-21 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S031) | Medinol, Ltd. | 2020-12-21 |
| Tridyne Vascular Sealant (P150016/S018) | Neomend, Inc. | 2020-12-21 |