| XIENCE PRIME Everolimus Eluting Coronary Stent System / SV / LL ; XIENCE Xpedition Everolimus Eluting Coronary Stent Sys (P110019/S095) | Abbott Vascular | 2018-01-25 |
| XIENCE V Everolimus Eluting Coronary Stent System / XIENCE nano Everolimus Eluting Coronary Stent System (P070015/S138) | Abbott Vascular, Inc. | 2018-01-25 |
| Implantable Cardioverter Defibrillator ICDs (P980049/S127) | MicroPort CRM USA, Inc. | 2018-01-25 |
| Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate, Punctua, Energen, Incepta CRT-D (P010012/S475) | Boston Scientific Corp | 2018-01-19 |
| EDWARDS INTUITY Elite Valve System, Aortic Valve and Delivery System (P150036/S023) | Edwards Lifesciences, LLC | 2018-01-19 |
| Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate, Perciva,Punctua, Energen, Incepta ICD (P960040/S416) | Boston Scientific | 2018-01-19 |
| Artegraft Collagen Vascular Graft (N16837/S023) | LeMaitre Vascular, Inc. | 2018-01-18 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S057) | Medtronic | 2018-01-18 |
| CoreValve Evolut R System and CoreValve Evolut PRO System (P130021/S049) | Medtronic, Inc. | 2018-01-18 |
| HeartLight Endoscopic Ablation System (P150026/S003) | Cardiofocus, Inc. | 2018-01-17 |
| Consulta, Syncra, Viva CRT-P (P010015/S351) | Medtronic, Inc. | 2018-01-17 |
| EnVeo PRO Delivery Catheter System, EnVeo PRO Loading System (P130021/S043) | Medtronic, Inc. | 2018-01-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S003) | ABBOTT MEDICAL | 2018-01-16 |
| Impella RP System (P170011/S004) | Abiomed, Inc. | 2018-01-16 |
| Bard E-LUMINEXX and LIFESTAR Vascular Stents (P080007/S021) | Bard Peripheral Vascular, Inc. | 2018-01-16 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S099) | Boston Scientific Corporation | 2018-01-16 |
| Cardiac Resynchronization Therapy Defibrillator Momentum, Vigilant, Resonate (P010012/S476) | Boston Scientific Corp | 2018-01-15 |
| Implantable Cardioverter Defibrillator / Momentur, Vigilant, Resonate, Perciva (P960040/S417) | Boston Scientific | 2018-01-15 |
| Hancock Modified Orifice Valved Conduit (P790007/S055) | Medtronic Heart Valves | 2018-01-12 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S100) | Boston Scientific Corporation | 2018-01-12 |
| Freestyle Aortic Root Bioprosthesis (P970031/S062) | Medtronic, Inc. | 2018-01-12 |
| Mosaic Porcine Bioprosthesis (P990064/S074) | Medtronic, Inc. | 2018-01-12 |
| Hancock II Porcine Bioprosthesis (P980043/S065) | Medtronic, Inc. | 2018-01-12 |
| Hancock Modified Orifice Valved Conduit (P870078/S040) | Medtronic, Inc. | 2018-01-12 |
| ThermoCool Smart Touch (P030031/S087) | Biosense Webster, Inc. | 2018-01-11 |
| ThermoCool Smart Touch SF Catheters (P040036/S062) | Biosense Webster, Inc. | 2018-01-11 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S026) | Cook Ireland, Ltd. | 2018-01-11 |
| EMBLEM MRI S-ICD; EMBLEM S-ICD (P110042/S101) | Boston Scientific Corporation | 2018-01-10 |
| DYNAGEN CRT-D AND X4 CRT-D; INOGEN CRT-D AND X4 CRT-D; ORIGEN CRT-D AND X4 CRT-D; AUTOGEN CRT-D AND X4 CRT-D; INCEPTA, E (P010012/S474) | Boston Scientific Corp | 2018-01-10 |
| DYNAGEN, INOGEN, ORIGEN, AUTOGEN EL ICD; DYNAGEN MINI, INOGEN MINI, ORIGEN MINI ICD; INCEPTA, ENERGEN, PUNCTUA ICD; MOME (P960040/S415) | Boston Scientific | 2018-01-10 |
| Inspiris Resilia Aortic Valve (P150048/S003) | Edwards Lifesciences, LLC | 2018-01-08 |
| Contak Renewal Models H125 and H120 with the Model 2865 Version 1.8 Application Software (P030005/S165) | Guidant Corp. | 2018-01-07 |
| Tendril MRI Cardiac Lead (P140033/S019) | ABBOTT MEDICAL | 2018-01-07 |
| Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead (P150012/S044) | Boston Scientific | 2018-01-07 |
| Latitude Programming System (P910077/S163) | Boston Scientific | 2018-01-07 |
| Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software (N970003/S217) | Boston Scientific Corp | 2018-01-07 |
| Ventak AV Aicd Ventak Prizm DR/VR, Vitality, Cofient and Teligen Automatic Implantable Cardiovetr Defibrillator System (P960040/S408) | Boston Scientific | 2018-01-07 |
| Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S467) | Boston Scientific Corp | 2018-01-07 |
| CardioMems HF System (P100045/S025) | ABBOTT MEDICAL | 2018-01-05 |
| Medical Adhesive (P880086/S292) | ABBOTT MEDICAL | 2018-01-05 |
| ENDOTAK RELIANCE S /GS /G (P910073/S147) | Boston Scientific | 2018-01-05 |
| Biosense Webster NaviStar ThermoCool Catheter (P030031/S085) | Biosense Webster, Inc. | 2018-01-05 |
| IS4/DF4 Connector Sleeve; Suture Sleeve; Suture Sleeve Kit (P950022/S113) | ABBOTT MEDICAL | 2018-01-05 |
| Lead Cap (IS-1/DF-1/SJ4/DF/IS4) IS4/DF4 Port Plug; DF-1 Receptacle Plug; IS-1 Receptacle Plug (P910023/S399) | ABBOTT MEDICAL | 2018-01-05 |
| Slit Suture Sleeve; Vein Pick (P030054/S343) | ABBOTT MEDICAL | 2018-01-05 |
| Micra Transcatheter Pacemaker System (P150033/S029) | Medtronic, Inc. | 2018-01-05 |
| IN.PACT Admiral Paclitaxel-Coated Balloon Catheter (P140010/S033) | Medtronic, Inc. | 2018-01-05 |
| HV splitter/adaptor kit; Sprint Quattro Lead (P920015/S205) | Medtronic, Inc. | 2018-01-04 |
| Attain Performa Lead (P080006/S117) | Medtronic, Inc. | 2018-01-04 |
| Amplia MRI CRT-D / Amplia MRI Quad CRT-D / Brava CRT-D / Brava Quad CRT-D / Claria MRI & Quad Quad CRT-D / Compia MRI & (P010031/S615) | Medtronic Cardiac Rhythm Disease Management | 2018-01-03 |
| BioGlue Surgical Adhesive (P010003/S029) | Cryolife, Inc. | 2018-01-03 |
| Allure, Allure Quadra, Quadra Allure MP (P030035/S163) | ABBOTT MEDICAL | 2018-01-03 |
| Assurity, Assurity+, Endurity (P880086/S291) | ABBOTT MEDICAL | 2018-01-03 |
| Evera MRI ICD / Evera S DR / S VR /XT DR / XT VR ICD; Visia AF MRI VR ICD / Visia AF VR ICD (P980016/S655) | Medtronic Cardiac Rhythm Disease Management | 2018-01-03 |
| Tridyne Vascular Sealant (P150016/S008) | Neomend, Inc. | 2018-01-02 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S047) | W. L. Gore & Associates, Inc. | 2017-12-28 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S108) | W. L. Gore & Associates, Inc. | 2017-12-28 |
| X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower (P160022) | ZOLL Medical Corporation | 2017-12-27 |
| Amplatzer Septal Occluder (P000039/S061) | ABBOTT MEDICAL | 2017-12-26 |
| Biocor Heart Valve (P040021/S033) | ABBOTT MEDICAL | 2017-12-26 |
| Therapy (Flexability) Ablation Catheters (P110016/S052) | ABBOTT MEDICAL | 2017-12-26 |
| Trifecta Heart Valve (P100029/S028) | ABBOTT MEDICAL | 2017-12-26 |
| CVX-300 Excimer Laser System (P910001/S102) | Spectranetics Corp. | 2017-12-22 |
| PreveLeak Surgical Sealant (P100030/S008) | Baxter Healthcare Corporation | 2017-12-21 |
| Evera MRI DF-1 ICD / Evera S DR /VR ICD / Evera XT VR ICD / Protecta ICD / Protecta XT ICD /Visia AF MRI DF 1 ICD / Visi (P980016/S654) | Medtronic Cardiac Rhythm Disease Management | 2017-12-21 |
| Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter (P150005/S014) | Boston Scientific Corp | 2017-12-21 |
| Amplia MRI CRT-D / Brava CRT-D / Claria & Compia MRI CRT-D / Protecta CR-d / Protecta XT CRT-D / Viva S CRT-D (P010031/S614) | Medtronic Cardiac Rhythm Disease Management | 2017-12-21 |
| LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger (P160012) | Physio-Control, Inc. | 2017-12-21 |
| Endurant/Endurant II/Endurant IIs Stent Graft Systems, Talent Occluder with Occluder Delivery System (P100021/S068) | Medtronic Vascular | 2017-12-20 |
| Resolute Integrity Coronary Stent Systems (P110013/S085) | Medtronic Vascular | 2017-12-20 |
| TRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip (P150016/S007) | Neomend, Inc. | 2017-12-20 |
| Integrity Coronary Stent System (P030009/S093) | Medtronic, Ireland | 2017-12-20 |
| Valiant Thoracic Stent Graft System (P100040/S033) | Medtronic Vascular | 2017-12-20 |
| Linox Smart, Protego, and Plexa (P980023/S083) | Biotronik, Inc. | 2017-12-19 |
| Siello, Solia, Setrox, and Safio (P950037/S184) | Biotronik, Inc. | 2017-12-19 |
| Emblem, Emblem MRI S-ICDs (P110042/S098) | Boston Scientific Corporation | 2017-12-19 |
| Intua, Invive, Valitude, Visionist, CRT-Ps (P030005/S170) | Guidant Corp. | 2017-12-19 |
| Accolade MRI, Essentio MRI, Formio MRI, Ingenio MRI, Proponent MRI, Vitalio MRI (P150012/S050) | Boston Scientific | 2017-12-19 |
| Autogen, Dynagen, Energen, Incepta, Inogen, Momentum, Origen, Perciva, Punctua, Resonate, Vigiliant, Vitality ICDs (P960040/S412) | Boston Scientific | 2017-12-19 |
| Autogen, Cognis, Dynagen, Energen, Incepta, Inogen, Momentum, Origen, Punctua, Resonate, Vigiliant, CRT-Ds (P010012/S472) | Boston Scientific Corp | 2017-12-19 |
| Accolade, Advantio, Altrua, Altrua 2, Essentio, Formio, Ingenio, Insignia, Proponent, Vitalio Pacemakers (N970003/S222) | Boston Scientific Corp | 2017-12-19 |
| Implantable Cardioverter Defibrillator (ICD) (P910023/S388) | ABBOTT MEDICAL | 2017-12-19 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S026) | Medinol, Ltd. | 2017-12-19 |
| High Voltage Active Fixation Lead, (P030054/S332) | ABBOTT MEDICAL | 2017-12-19 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) (P950022/S109) | ABBOTT MEDICAL | 2017-12-19 |
| Low Voltage Active Fixation Lead (P140033/S010) | ABBOTT MEDICAL | 2017-12-19 |
| Rebel Platinum Chromium Coronary Stent System (P130030/S047) | Boston Scientific Corp | 2017-12-15 |
| Amplia MRI CRT-D, Brava CRT-D, Claria MRI CRT-D, Compia MRI CRT-D, Viva S CRT-D, Viva XT CRT-D (P010031/S613) | Medtronic Cardiac Rhythm Disease Management | 2017-12-15 |
| HeartWare HVAD System (P100047/S101) | Medtronic | 2017-12-15 |
| Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI VR ICD, Visia AF VR ICD (P980016/S652) | Medtronic Cardiac Rhythm Disease Management | 2017-12-15 |
| Multi-Link 8 Coronary Stent System (P020047/S065) | Abbott Vascular | 2017-12-15 |
| Avalus Bioprosthesis, Model 400 (P170006/S005) | Medtronic, Inc. | 2017-12-15 |
| Express SD Renal Monorail Premounted Stent System (P060006/S089) | Boston Scientific Corp | 2017-12-15 |
| Cordis Precise Nitinol Stent System (P030047/S034) | Cordis US Corporation | 2017-12-15 |
| On-X Ascending Aortic Prosthesis (P000037/S051) | On-X Life Technologies, Inc. | 2017-12-14 |
| HV splitter/adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Lead, Subcutaneous Lead, Transve (P920015/S203) | Medtronic, Inc. | 2017-12-14 |
| Attain Ability Lead, Attain Performa Lead (P080006/S116) | Medtronic, Inc. | 2017-12-14 |
| Cordis Exoseal Vascular Closure Device (P100013/S015) | Cordis US Corporation | 2017-12-14 |
| Epicardial Patch Lead (P900061/S147) | Medtronic Cardiac Rhythm Disease Management | 2017-12-14 |
| CapSure Epicardial Pacing Lead (P950024/S077) | Medtronic, Inc. | 2017-12-14 |