| HeartMate 3 Left Ventricular Assist System (P160054/S002) | ABBOTT MEDICAL | 2017-10-12 |
| Thoratec HeartMate II and HeartMate 3 Ventricular Assist System (LVAS) (P060040/S068) | ABBOTT MEDICAL | 2017-10-12 |
| HeartMate II Left Ventricular Assist System (P060040/S069) | ABBOTT MEDICAL | 2017-10-12 |
| Chilli II (P980003/S080) | Boston Scientific Corp | 2017-10-11 |
| Blazer II XP/ Blazer Prime XP / Intella Tip MiFi XP / IntellaNav, IntellaNav MiFi XP (P020025/S107) | Boston Scientific | 2017-10-11 |
| Blazer OI / IntellaNav OI / Intella Tip MiFi OI (P150005/S028) | Boston Scientific Corp | 2017-10-11 |
| Blazer II HTD / Blazer Prime HTD (P920047/S103) | Boston Scientific Corp | 2017-10-11 |
| ICDs: PUNCTUA, ENERGEN, INCEPTA (P960040/S404) | Boston Scientific | 2017-10-11 |
| GORE CARDIOFORM Septal Occluder (P050006/S058) | W. L. Gore & Associates, Inc. | 2017-10-11 |
| CRT-Ds: DYNAGEN, VIGILANT, MOMENTUM (P010012/S463) | Boston Scientific Corp | 2017-10-11 |
| GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (P130006/S043) | W. L. Gore & Associates, Inc. | 2017-10-10 |
| WEBSTER CATHETER, CELSIUS THERMOCOOL Catheter, CELSIUS Catheter (P950005/S067) | Biosense Webster, Inc. | 2017-10-10 |
| CELSIUS DS Catheter, NAVISTAR DS Catheter (P010068/S055) | Biosense Webster, Inc. | 2017-10-10 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S059) | W. L. Gore & Associates, Inc. | 2017-10-10 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S104) | W. L. Gore & Associates, Inc. | 2017-10-10 |
| ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM (P150023/S003) | Abbott Vascular, Inc. | 2017-10-10 |
| NaviStar Catheter (P990025/S054) | Biosense Webster, Inc. | 2017-10-10 |
| CELSIUS THERMOCOOL Catheter (P030031/S083) | Biosense Webster, Inc. | 2017-10-10 |
| Chilli II Cooled Ablation System (P980003/S081) | Boston Scientific Corp | 2017-10-06 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI Ablation Catheter (P150005/S029) | Boston Scientific Corp | 2017-10-06 |
| Open Pivot Heart Valve (P990046/S051) | Medtronic Ats Medical, Inc. | 2017-10-06 |
| Amploa MRI CRT-D, Quad CRT-D, Brava CRT-D, Quad CRT-D, Claria MRI CRT-D, Quad CRT-D, Compia MRI CRT-D Quad CRT-D, Viva Q (P010031/S602) | Medtronic Cardiac Rhythm Disease Management | 2017-10-05 |
| INGEVITY Active-Fixation Non-MRI / Active-Fixation MRI (P150012/S038) | Boston Scientific | 2017-10-05 |
| Azure XT DR/SR Mri SureScan IPG; Azure S DR/SR MRI Sure Scan IPG (P980035/S520) | Medtronic, Inc. | 2017-10-05 |
| Evera MRI DF ICD, MRI ICD, S DR ICD, S VR ICD, XT DR ICD, XT VR ICD - Visia AF MRI DFI ICD, AF MRI VR ICD, AF VR ICD (P980016/S641) | Medtronic Cardiac Rhythm Disease Management | 2017-10-05 |
| Fluency Plus Endovascular Stent Graft (P130029/S007) | Bard Peripheral Vascular, Inc. | 2017-10-05 |
| GORE TIGRIS VASCULAR STENT (P160004/S006) | W. L. Gore & Associates, Inc. | 2017-10-04 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S080) | Medtronic Vascular | 2017-10-04 |
| Integrity Coronary Stent Systems (P030009/S092) | Medtronic, Ireland | 2017-10-04 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S053) | Edwards Lifesciences, LLC | 2017-10-04 |
| Edwards Expandable Introducer Sheath Set (P130009/S082) | Edwards Lifesciences, LLC | 2017-10-04 |
| Hancock Valved Conduit (P870078/S038) | Medtronic, Inc. | 2017-10-03 |
| Hancock II and Hancock Ultra II Bioprosthesis (P980043/S063) | Medtronic, Inc. | 2017-10-03 |
| Melody Transcatheter Pulmonary Valve (TPV) (P140017/S008) | Medtronic, Inc. | 2017-10-03 |
| Edwards Commander Delivery System (P140031/S054) | Edwards Lifesciences, LLC | 2017-10-03 |
| Hancock Modified Orific Valved Conduit. (P790007/S053) | Medtronic Heart Valves | 2017-10-03 |
| Freestyle Bioprosthesis (P970031/S059) | Medtronic, Inc. | 2017-10-03 |
| Arctic Front Cryoablation System (CryoConsole) (P100010/S065) | Medtronic Cryocath, LP | 2017-10-03 |
| Avalus Bioprosthesis Valve (P170006/S001) | Medtronic, Inc. Heart Valve Division | 2017-10-03 |
| Mosaic Bioprosthesis & Mosaic Ultra Bioprosthesis (P990064/S071) | Medtronic, Inc. | 2017-10-03 |
| Freezor CryoAblation System (CryoConsole) (P020045/S083) | Medtronic Cryocath, LP | 2017-10-03 |
| Evolut R Transcatheter Aortic Valve (TAV) (P130021/S042) | Medtronic, Inc. | 2017-10-03 |
| TactiSys Quartz Mounting Bracket, TactiSys Quartz Equipment (P130026/S026) | St Jude Medical | 2017-10-02 |
| Misago RX Self-expanding Peripheral Stent (P140002/S008) | Terumo Medical Corporation | 2017-09-29 |
| Model 3501 EMBLEM S-ICD subcutaneous Electrode (P110042/S077) | Boston Scientific Corporation | 2017-09-29 |
| Endurant II/IIs Stent Graft System (P100021/S063) | Medtronic Vascular | 2017-09-29 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S056) | Syncardia Systems, LLC | 2017-09-29 |
| FlexAbility Ablation Catheters (Bi & Uni Directional) (P110016/S034) | ABBOTT MEDICAL | 2017-09-29 |
| ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, PERCIVA, RESONATE; Implantable Cardioverter Defibrillator(ICD) (P960040/S402) | Boston Scientific | 2017-09-28 |
| MynxGrip Vascular Closure Device (P040044/S077) | Cordis US Corporation | 2017-09-28 |
| AngioJet Ultra Thrombectomy System (P980037/S067) | Boston Scientific Corp | 2017-09-28 |
| Sapien 3 Transcatheter Heart Valve (P140031/S052) | Edwards Lifesciences, LLC | 2017-09-28 |
| ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE; Implantable Cardiac Resynchronization Therapy Defibrilla (P010012/S461) | Boston Scientific Corp | 2017-09-28 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S015) | Boston Scientific Corp | 2017-09-28 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S042) | W. L. Gore & Associates, Inc. | 2017-09-27 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S058) | W. L. Gore & Associates, Inc. | 2017-09-27 |
| GORE TAG Thoracic Endoprosthesis (P040043/S095) | W. L. Gore & Associates, Inc. | 2017-09-27 |
| GORE VIABAHN Endoprosthesis (P040037/S103) | W. L. Gore & Associates, Inc. | 2017-09-27 |
| HeartWare HVAD System (P100047/S090) | Medtronic | 2017-09-27 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S147) | W. L. Gore & Associates, Inc. | 2017-09-27 |
| HeartWare Ventricular Assist System (P100047/S109) | Medtronic | 2017-09-27 |
| GORE CADIOFORM Septal Occluder (P050006/S061) | W. L. Gore & Associates, Inc. | 2017-09-27 |
| Fortify, Fortify Assura (P910023/S390) | ABBOTT MEDICAL | 2017-09-26 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S334) | ABBOTT MEDICAL | 2017-09-26 |
| Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav XP, IntellaNav MiFi XP (P020025/S106) | Boston Scientific | 2017-09-26 |
| Blazer II HTD, Blazer Prime HTD (P920047/S102) | Boston Scientific Corp | 2017-09-26 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI (P150005/S027) | Boston Scientific Corp | 2017-09-26 |
| Chill II (P980003/S079) | Boston Scientific Corp | 2017-09-26 |
| ICDs: Origen, Inogen, Dynagen, Momentum EL ICD, Autogen, Vigiliant EL ICD, Perciva ICD, Resonate EL ICD, Perciva HF ICD, (P960040/S403) | Boston Scientific | 2017-09-25 |
| CRT-Ds: Origen, Momentum, Inogen, Dynagen, Autogen, Vigilant, Resonate, Punctua, Energen and Incepta (P010012/S462) | Boston Scientific Corp | 2017-09-25 |
| Pacemakers: Advantio, Ingenio, Vitalio, Formio, Essentio, Proponent, Accolade, and Altrua 2 (N970003/S212) | Boston Scientific Corp | 2017-09-25 |
| CRT-Ps: Invive, Valitude, and Visionist (P030005/S160) | Guidant Corp. | 2017-09-25 |
| Pacemakers: Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, and Accolade MRI (P150012/S037) | Boston Scientific | 2017-09-25 |
| Biocor and Epic Heart Valves (P040021/S032) | ABBOTT MEDICAL | 2017-09-22 |
| AMPLATZER PFO OCCLUDER (P120021/S002) | ABBOTT MEDICAL | 2017-09-22 |
| Synergy Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and over the wire (P150003/S034) | Boston Scientific Corporation | 2017-09-22 |
| Attain Performa Lead Models 4298, 4398, 4598 (P080006/S115) | Medtronic, Inc. | 2017-09-22 |
| Promus Element plus Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and over the wire/ Promus Premie (P110010/S146) | Boston Scientific Corp | 2017-09-22 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033/S006) | ABBOTT MEDICAL | 2017-09-21 |
| Impella 2.5 System and Impella Ventricular Support Sustems (P140003/S023) | Abiomed, Inc. | 2017-09-21 |
| ST JUDE MEDICAL EPIC HF SYSTEM (P030054/S326) | ABBOTT MEDICAL | 2017-09-21 |
| ELCA Coronary Laser Atherectomy Catheters (P910001/S099) | Spectranetics Corp. | 2017-09-21 |
| Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D (P010031/S599) | Medtronic Cardiac Rhythm Disease Management | 2017-09-21 |
| Viabahn Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (P040037/S102) | W. L. Gore & Associates, Inc. | 2017-09-21 |
| ALTRUA 2 /ESSENTIO/ PROPONENT/ ACCOLADE (N970003/S209) | Boston Scientific Corp | 2017-09-21 |
| AMPLATZER Duct Occluder II (P020024/S048) | ABBOTT MEDICAL | 2017-09-21 |
| VALITUDE / VALITUDE X4 / VISIONIST / VISIONIST X4 (P030005/S157) | Guidant Corp. | 2017-09-21 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S384) | ABBOTT MEDICAL | 2017-09-21 |
| Viabahn Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (P130006/S041) | W. L. Gore & Associates, Inc. | 2017-09-21 |
| LifeVest Wearable Defibrillator (P010030/S099) | Zoll Manufacturing Corporation | 2017-09-21 |
| ESSENTIO MRI / PROPONENT MRI / ACCOLADE MRI (P150012/S034) | Boston Scientific | 2017-09-21 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S001) | Edwards Lifesciences, LLC | 2017-09-21 |
| Maximo II ICD, Protecta ICD, Protecta VR ICD, Protecta XT ICD, Secura DR ICD, Secura ICD, Virtuoso II DR/VR ICD (P980016/S638) | Medtronic Cardiac Rhythm Disease Management | 2017-09-21 |
| TVL(TM) LEAD SYSTEM (P950022/S105) | ABBOTT MEDICAL | 2017-09-21 |
| Impella RP System (P170011) | Abiomed, Inc. | 2017-09-20 |
| ENDOTAK RELIANCE, (Defibrillation Leads) (P910073/S142) | Boston Scientific | 2017-09-20 |
| RESONATE, VIGILANT, PERCIVA NG4 ICDs AUTOGEN, DYNAGEN, INOGEN, ORIGEN NG3 ICDs (P960040/S395) | Boston Scientific | 2017-09-20 |
| INGEVITY MRI Leads, Slit Suture Sleeve Accessory for INGEVITY Leads (Pacing Leads and Accessories) (P150012/S032) | Boston Scientific | 2017-09-20 |
| RESONATE, VIGILANT NG4 CRT-Ds, AUTOGEN, DYNAGEN, INOGEN, ORIGEN NG3 CRT-Ds, ACUITY X4 Leads, Slit Suture Sleeve Accesso (P010012/S453) | Boston Scientific Corp | 2017-09-20 |
| Aorfix AAA Flexible Stent Graft System with Aorflex Delivery Device (P110032/S013) | Lombard Medical Limited | 2017-09-20 |