| Pacemakers Reply SR/DR and Esprit SR/DR (P950029/S120) | MicroPort CRM USA, Inc. | 2018-03-15 |
| HeartWare HVAD System (P100047/S114) | Medtronic | 2018-03-15 |
| Resolute Integrity Coronary Stent Systems (P110013/S087) | Medtronic Vascular | 2018-03-15 |
| Attain StarFix Model 4195 Lead (P060039/S083) | Medtronic, Inc. | 2018-03-15 |
| Carotid WALLSTENT (P050019/S030) | Boston Scientific Corp | 2018-03-13 |
| Ultrasonic Cleaning Machine (P920015/S209) | Medtronic, Inc. | 2018-03-13 |
| Tendril MRI (P140033/S023) | ABBOTT MEDICAL | 2018-03-13 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S002) | The Spectranetics Corp. | 2018-03-12 |
| Amplatzer Septal Occluder / Amplatzer Multi-Fenestrated Septal Occluder-Cribriform Occluder (P000039/S062) | ABBOTT MEDICAL | 2018-03-12 |
| Amplatzer Muscular VSD Occluder (P040040/S033) | ABBOTT MEDICAL | 2018-03-12 |
| FlexAbility Ablation Catheter / FlexAbility Ablation Catheter Sensor Enabled (P110016/S054) | ABBOTT MEDICAL | 2018-03-12 |
| Subcutaneous ICD Device (S-ICD): EMBLEM, EMBLEM MRI (P110042/S104) | Boston Scientific Corporation | 2018-03-12 |
| Carpentier - Edwards Perimount Magna East Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S174) | Edwards Lifesciences, LLC | 2018-03-12 |
| Implantable Cardioverter Defibrillator (ICD): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIG (P960040/S422) | Boston Scientific | 2018-03-12 |
| Livewire TC Ablation Catheter / Safire Bi-Directional Catheter (P960016/S072) | St Jude Medical | 2018-03-12 |
| Edwards Intuity Elite Valve System (P150036/S025) | Edwards Lifesciences, LLC | 2018-03-12 |
| Implantable Cardiac Resynchronization Therpy Defibrillator (CRT-D): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, (P010012/S481) | Boston Scientific Corp | 2018-03-12 |
| Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S054) | Boston Scientific | 2018-03-12 |
| Edwards Pericardial Aortic Bioprosthesis (Resilia tissue) (P150048/S016) | Edwards Lifesciences, LLC | 2018-03-12 |
| Accolade Non-MRI Pacemakers: ADVANTIO, INGENIO, VITALIO, ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE (N970003/S226) | Boston Scientific Corp | 2018-03-12 |
| Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Devices: INVIVE TM, INTUA TM, VALITUDE, VALITUDE X4, VISION (P030005/S174) | Guidant Corp. | 2018-03-12 |
| Amplatzer Duct Occluder / Amplatzer Duct Occluder II (P020024/S051) | ABBOTT MEDICAL | 2018-03-12 |
| TatiCath Quartz Contact Force Ablation Catheter (P130026/S031) | St Jude Medical | 2018-03-12 |
| Amplatzer Patent foramen Ovale Occluder (P120021/S007) | ABBOTT MEDICAL | 2018-03-12 |
| PLATINIUM 4LV CRT-D (P060027/S093) | MicroPort CRM USA, Inc. | 2018-03-11 |
| Reply SR / Esprit SR / Reply DR / Esprit DR (P950029/S118) | MicroPort CRM USA, Inc. | 2018-03-11 |
| PLATINIUM VR / DR / CRT-D (P980049/S128) | MicroPort CRM USA, Inc. | 2018-03-11 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S356) | Medtronic, Inc. | 2018-03-09 |
| Astra XT DR, Astra S DR, Astra S SR, Astra XT SR MIR IPG and Azure S DR, Azure S SR, Azure XT DR, Azure XT SR MRI IPG (P980035/S535) | Medtronic, Inc. | 2018-03-09 |
| FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled (P110016/S055) | ABBOTT MEDICAL | 2018-03-09 |
| Arctic Front Advance Cardiac Cryoablation Catheter (P100010/S074) | Medtronic Cryocath, LP | 2018-03-09 |
| AMPLATZER PFO Occluder (P120021/S006) | ABBOTT MEDICAL | 2018-03-08 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S050) | W. L. Gore & Associates, Inc. | 2018-03-08 |
| GORE VIABAHN Endoprosthesis (P040037/S111) | W. L. Gore & Associates, Inc. | 2018-03-08 |
| Perceval Sutureless Heart Valve (P150011/S012) | Corcym S.r.l. | 2018-03-07 |
| TactiCath Quartz Ablation Catheter (P130026/S030) | St Jude Medical | 2018-03-07 |
| Ascendra+ and NovaFlex+ Delivery System, Crimper and Edwards Expandable Introducer Sheath Set (P130009/S086) | Edwards Lifesciences, LLC | 2018-03-07 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S014) | Edwards Lifesciences, LLC | 2018-03-07 |
| Edwards COmmander Delivery System (P140031/S061) | Edwards Lifesciences, LLC | 2018-03-07 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S024) | Medinol, Ltd. | 2018-03-07 |
| Solo Smart Stentless Heart Valve (P130011/S006) | Corcym Canada Corp | 2018-03-07 |
| Therapy Cool Path, Safire BLU, Safire BLU SP, Therapy Cool Path SP, 1500T9-CP Generators (P060019/S042) | Irvine Biomedical, Inc. | 2018-03-06 |
| Therapy Dual 8, Therapy 8mm Thermistor, Safire TX Ablation Catheters, 1500T6 RF Generators, 1500T9 RF Generators (P040042/S040) | Irvine Biomedical,Inc.(Ibi) | 2018-03-06 |
| SJM Masters Series Mechanical Heart Valve, 15mm HP (P810002/S101) | ABBOTT MEDICAL | 2018-03-06 |
| GORE VIABAHN Endoprosthesis (P040037/S110) | W. L. Gore & Associates, Inc. | 2018-03-06 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S049) | W. L. Gore & Associates, Inc. | 2018-03-06 |
| Therapy Ablation Catheters (P040014/S034) | Irvine Biomedical, Inc. | 2018-03-06 |
| Livewire TC Steerable Electrophysiology Catheter, Safire Bi-Directional Ablation Catheter (P960016/S071) | St Jude Medical | 2018-03-06 |
| RF Conductr MC; RF Marinr 5Fr; RF Marinr 7Fr; and Unipolar Mapping RF Marinr 7Fr (P930029/S058) | Medtronic, Inc. | 2018-03-06 |
| TactiCath Quartz Set (P130026/S029) | St Jude Medical | 2018-03-06 |
| Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP, Therapy C (P110016/S053) | ABBOTT MEDICAL | 2018-03-06 |
| CardioMEMS patient and hospital electronics (P100045/S022) | ABBOTT MEDICAL | 2018-03-06 |
| Current, Fortify, Fortify Assura, Ellipse (P910023/S405) | ABBOTT MEDICAL | 2018-03-05 |
| Assurity, Endurity (P880086/S296) | ABBOTT MEDICAL | 2018-03-05 |
| Assurity MRI, Endurity MRI (P140033/S026) | ABBOTT MEDICAL | 2018-03-05 |
| Assure CRT-P (P030035/S167) | ABBOTT MEDICAL | 2018-03-05 |
| XIENCE Prime/Xpedition/Alpine/Sierra Everolimus Eluting Coronary Stent System (SV, LL) (P110019/S096) | Abbott Vascular | 2018-03-05 |
| XIENCE V/nano Everolimus Eluting Coronary Stent System (P070015/S139) | Abbott Vascular, Inc. | 2018-03-05 |
| MULTI-LINK 8 Coronary, 8 LL Coronary, and 8 SV Coronary Stent System (P020047/S067) | Abbott Vascular | 2018-03-05 |
| Ellipse (P910023/S404) | ABBOTT MEDICAL | 2018-03-05 |
| Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI IPG (P980035/S533) | Medtronic, Inc. | 2018-03-02 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S354) | Medtronic, Inc. | 2018-03-02 |
| Sprint Quattro Secure S MRI SureScan Lead & Sprint Quattro Secure MRI SureScan Lead (P920015/S204) | Medtronic, Inc. | 2018-03-01 |
| Primo MRITM SureScan TM & Mirro MRITM SureScan TM (P980016/S653) | Medtronic Cardiac Rhythm Disease Management | 2018-03-01 |
| CapSure Sense MRI SureScan Lead (P830061/S153) | Medtronic Cardiac Rhythm Disease Management | 2018-03-01 |
| CapSureFix Novus MRI SureScan Lead (P930039/S179) | Medtronic, Inc. | 2018-03-01 |
| CapSureFix MRI SureScan Lead (P090013/S269) | Medtronic, Inc. | 2018-03-01 |
| SelectSecure MRI SureScan Lead (P030036/S098) | Medtronic Cardiac Rhythm Disease Management | 2018-03-01 |
| Arctic Front Advance Cardiac CryoAblation Catheter (P100010/S071) | Medtronic Cryocath, LP | 2018-02-28 |
| INSPIRIS RESILIA Aortic Valve (P150048/S015) | Edwards Lifesciences, LLC | 2018-02-28 |
| Edwards Pericardial Aortic Bioprosthesis and Inspiris Resilia Aortic (P150048/S017) | Edwards Lifesciences, LLC | 2018-02-28 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S005) | W. L. Gore & Associates, Inc. | 2018-02-28 |
| Trifecta and Trifecta GT (P100029/S030) | ABBOTT MEDICAL | 2018-02-27 |
| Mechanical Heart Valves and Vlaved Grafts (P810002/S106) | ABBOTT MEDICAL | 2018-02-27 |
| CardioMEMS HF System (P100045/S028) | ABBOTT MEDICAL | 2018-02-26 |
| Lutonix Drug Coated Balloon (P170003/S001) | Lutonix | 2018-02-26 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S037) | Boston Scientific Corporation | 2018-02-23 |
| Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Premier Everolimus-Eluting Pla (P110010/S153) | Boston Scientific Corp | 2018-02-23 |
| CareLink Programmer and Encore Programmer Software (P890003/S384) | Medtronic, Inc. | 2018-02-23 |
| Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S031) | ABBOTT MEDICAL | 2018-02-23 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, Verity ADx (P880086/S295) | ABBOTT MEDICAL | 2018-02-22 |
| Microny (P970013/S077) | ABBOTT MEDICAL | 2018-02-22 |
| HeartWare Left Ventricular Assist System (P100047/S117) | Medtronic | 2018-02-22 |
| Durata, Optisure (P950022/S115) | ABBOTT MEDICAL | 2018-02-22 |
| Current+, Fortify, Fortify Assura, Ellipse (P910023/S403) | ABBOTT MEDICAL | 2018-02-22 |
| Tendril SDX Lead, Tendril ST Lead, OptiSense, Tentril STS Lead (P960013/S095) | ABBOTT MEDICAL | 2018-02-22 |
| Anthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF (P030035/S166) | ABBOTT MEDICAL | 2018-02-22 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S029) | Boston Scientific Corp | 2018-02-22 |
| Assurity MRI, Endurity MRI, Tendril MRI (P140033/S025) | ABBOTT MEDICAL | 2018-02-22 |
| Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet, Quartet (MR Conditio (P030054/S348) | ABBOTT MEDICAL | 2018-02-22 |
| IsoFlex Optim (P960030/S056) | ABBOTT MEDICAL | 2018-02-22 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DDR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Protecta ICD, Prot (P980016/S657) | Medtronic Cardiac Rhythm Disease Management | 2018-02-21 |
| Selox ST/JT; Siello S; Setrox S, Solia S, Safio S (P950037/S185) | Biotronik, Inc. | 2018-02-21 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Quadripolar C (P010015/S352) | Medtronic, Inc. | 2018-02-21 |
| Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S531) | Medtronic, Inc. | 2018-02-21 |
| 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/S617) | Medtronic Cardiac Rhythm Disease Management | 2018-02-21 |
| TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (P050023/S115) | Biotronik, Inc. | 2018-02-21 |
| MULTI-LINK 8 Coronary Stent System and SV/LL Coronary Stent System (P020047/S068) | Abbott Vascular | 2018-02-21 |
| NG3 Cardiac Resynchronization Therapy Defibrillators - Origen, Inogen, Dynagen, Autogen / NG4 Cardiac Resynchronization (P010012/S479) | Boston Scientific Corp | 2018-02-21 |
| XIENCE PRIME/SV/LL and XIENCE/SV/LL and XIENCE Alpine and XIENCE Sierra Everolimus Eluting Coronary Stent System (P110019/S097) | Abbott Vascular | 2018-02-21 |