| Rotablator Rotational Atherectomy System (P900056/S168) | Boston Scientific Corp | 2017-12-01 |
| Evera MRI DF-I ICD,EVERA MRI ICD, Evera S DR/S VR/XT DR/ XT VR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maxmo II ICD, (P980016/S640) | Medtronic Cardiac Rhythm Disease Management | 2017-12-01 |
| Revo MRI SureScan IPG (P090013/S263) | Medtronic, Inc. | 2017-12-01 |
| Emblem S-ICD System Model A209 / Emblem MRI S-ICD System Model A219 (P110042/S096) | Boston Scientific Corporation | 2017-12-01 |
| Adapta, Versa, Sensia IPG, Adapta, Versa Sensia IPG, Advisa DR IPG, Advisa DR /SR MRI IPG, Astra S DR/S SR XTDR/ XT SR M (P980035/S519) | Medtronic, Inc. | 2017-12-01 |
| Accolade MRI, Essentio MRI, Proponent MRI (Accolade MRI) (P150012/S045) | Boston Scientific | 2017-12-01 |
| Express SD Monorail Premounted Stent System (P060006/S088) | Boston Scientific Corp | 2017-12-01 |
| Consulta CRT-P, Percepta Biploar CRT-P. Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P; Sola (P010015/S343) | Medtronic, Inc. | 2017-12-01 |
| Accolade, Altrua 2, Essentio, Proponent (Accolade), Advantio, Ingenio, Vitalio, Formio (Ingenio) (N970003/S218) | Boston Scientific Corp | 2017-12-01 |
| CareLink Express Monitor, Monitor CardioSight Reader, My CareLink Patient Monitor. (P890003/S381) | Medtronic, Inc. | 2017-12-01 |
| Micra TPS (P150033/S027) | Medtronic, Inc. | 2017-12-01 |
| SynCardia temporary Total Artificial Heart (TAH-t) System; Freedom Driver System (P030011/S058) | Syncardia Systems, LLC | 2017-12-01 |
| Amplia MRI CRT-D/ Amplia MRI Quad CRT-D; Brava CRT-D/ Brava Quad CRT-D; Claria MRI CRT-D. Claria MRI CRT-D; Compia MRI C (P010031/S601) | Medtronic Cardiac Rhythm Disease Management | 2017-12-01 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S109) | Boston Scientific | 2017-12-01 |
| PROMUS Elemen Plus Everolimus-Eiuting Stent System/ PROMUS PREMIER Everolimus-Eiuting Platinum Chromium Coronary Stent S (P110010/S149) | Boston Scientific Corp | 2017-12-01 |
| Plasma Treatment System (P910073/S144) | Boston Scientific | 2017-12-01 |
| Autogen, Dynagen, Inogen, Origen (NG3 CRT-Ds), Momentum, Resonate, Vigilant (NG4 CRT-Ds) (P010012/S468) | Boston Scientific Corp | 2017-12-01 |
| Valitude, Valitude X4, Visionist, Visionist X4 (Accolade (CRT-Ps), Intua, Invive (Ingenio CRT-Ps) (P030005/S166) | Guidant Corp. | 2017-12-01 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S046) | Boston Scientific Corp | 2017-12-01 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S032) | Boston Scientific Corp | 2017-12-01 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S083) | Boston Scientific Corp | 2017-12-01 |
| Autogen, Dynagen, Inogen, Origen (NG3 ICDs), Momentum, Vigilant, Perciva, Resonate (NG4 ICDs) (P960040/S409) | Boston Scientific | 2017-12-01 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S106) | Boston Scientific Corp | 2017-12-01 |
| RESILIA Aortic Valve (P150048/S008) | Edwards Lifesciences, LLC | 2017-11-30 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMs (P110013/S065) | Medtronic Vascular | 2017-11-30 |
| Adapta, Versa, Sensia IPG, Attesta IPG, Sphera IPG (P980035/S524) | Medtronic, Inc. | 2017-11-30 |
| FlexAbility Ablation Catheter/ FlexAbility Ablation Catheter, Sensor Enabled (P110016/S051) | ABBOTT MEDICAL | 2017-11-29 |
| Advisa DR IPG, Advisa DR MRI IPG (P980035/S518) | Medtronic, Inc. | 2017-11-29 |
| TRIDYNE Vascular Sealant (P150016/S006) | Neomend, Inc. | 2017-11-29 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S038) | Bard Peripheral Vascular | 2017-11-28 |
| Active Fixation INGEVITY Leads (P150012/S047) | Boston Scientific | 2017-11-28 |
| Lutonix Drug Coated Balloon (P130024/S020) | Lutonix | 2017-11-28 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S006) | Bard Peripheral Vascular, Inc. | 2017-11-28 |
| EluNIR™ Ridaforolimus Eluting Coronary Stent System (P170008) | Medinol, Ltd. | 2017-11-28 |
| EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System; (P110023/S024) | Medtronic Vascular, Inc. | 2017-11-27 |
| SAPIEN 3 Transcatheter Heart Valve (P140031/S055) | Edwards Lifesciences, LLC | 2017-11-27 |
| Automated Impella Controller (P140003/S025) | Abiomed, Inc. | 2017-11-27 |
| Arctic Front Cardiac CryoAblation System (P100010/S068) | Medtronic Cryocath, LP | 2017-11-27 |
| IntraStent DoubleStrut Stent; Visi-Pro Balloon-Expandable Peripheral Stent System (Ilac) (P030045/S004) | Medtronic Vascular, Inc. | 2017-11-27 |
| Protege GPS and Protege RX Carotid Stent System; Protege GPS Self-expanding Peripheral Stent System (Iliac) (P060001/S026) | Medtronic Vascular, Inc. | 2017-11-27 |
| Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis (P150048/S007) | Edwards Lifesciences, LLC | 2017-11-27 |
| SAPIEN XT Transcatheter Heart Valve (P130009/S083) | Edwards Lifesciences, LLC | 2017-11-27 |
| EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) (P110042/S095) | Boston Scientific Corporation | 2017-11-27 |
| TactiCath Quartz Set (P130026/S027) | St Jude Medical | 2017-11-27 |
| EDWARDS INTUITY ELITE Valve System (P150036/S020) | Edwards Lifesciences, LLC | 2017-11-27 |
| Freezor Cardiac CryoAblation System (P020045/S084) | Medtronic Cryocath, LP | 2017-11-27 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with the ThermaFix (P860057/S170) | Edwards Lifesciences, LLC | 2017-11-27 |
| HeartWare Ventricular Assist System (P100047/S116) | Medtronic | 2017-11-22 |
| Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S027) | ABBOTT MEDICAL | 2017-11-21 |
| Blazer Open-Irrigated Ablation Catheter System (P150005/S031) | Boston Scientific Corp | 2017-11-21 |
| CoreValve Evolut R System and CoreValve Evolut PRO System (P130021/S046) | Medtronic, Inc. | 2017-11-21 |
| Avalus Bioprosthesis (P170006/S004) | Medtronic, Inc. | 2017-11-21 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S048) | Edwards Lifesciences, LLC | 2017-11-20 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S047) | Edwards Lifesciences, LLC | 2017-11-20 |
| Water for Injection Sterile, USP (P100030/S009) | Baxter Healthcare Corporation | 2017-11-20 |
| MyCareLink Patient Monitor Telemetry Head Printed Circuit Board (P890003/S380) | Medtronic, Inc. | 2017-11-20 |
| HeartWare Ventricular Assist System (P100047/S113) | Medtronic | 2017-11-19 |
| Laser Angle Measurement Tool for Open and Close Leaflet Angles Measurement (P990046/S052) | Medtronic Ats Medical, Inc. | 2017-11-18 |
| LifeVest Wearable Defibrillator (P010030/S101) | Zoll Manufacturing Corporation | 2017-11-17 |
| SMART-MSP (P010012/S464) | Boston Scientific Corp | 2017-11-17 |
| Diamondback 360 Coronary Orbital Atherectomy System (OAS) Micro Crown Orbital Atherectomy Device (OAD) (P130005/S020) | Cardiovascular Systems, Inc. | 2017-11-17 |
| SMART-MSP (P960040/S405) | Boston Scientific | 2017-11-17 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S148) | Boston Scientific Corp | 2017-11-17 |
| SJM Masters Series mechanical heart valve, SJM Regent Valve, SJM Masters Series Aortic Valved Graft with Hemashield Tech (P810002/S105) | ABBOTT MEDICAL | 2017-11-16 |
| GORE VIABAHN Endoprosthesis (P040037/S106) | W. L. Gore & Associates, Inc. | 2017-11-16 |
| Wolverine Coronary Cutting Balloon (P950020/S087) | Boston Scientific Corp | 2017-11-16 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S045) | W. L. Gore & Associates, Inc. | 2017-11-16 |
| Mosaic Bioprosthesis (P990064/S073) | Medtronic, Inc. | 2017-11-16 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S001) | Medtronic Vascular | 2017-11-16 |
| Avalus (P170006/S003) | Medtronic, Inc. | 2017-11-16 |
| Freestyle Bioprosthesis (P970031/S061) | Medtronic, Inc. | 2017-11-16 |
| CoreValve, Evolut-R Evolut PRO (P130021/S045) | Medtronic, Inc. | 2017-11-16 |
| Wolverine Coronary Cutting Balloon (Monorail; Over-theWire) (P950020/S086) | Boston Scientific Corp | 2017-11-15 |
| LifeStent Vascular Stent System (P070014/S053) | Bard Peripheral Vascular, Inc. | 2017-11-14 |
| Consulta CRT-P, Percepta Bipolar CRT-P / Percepta Quadripolar CRT-P, Serena Bipolar CRT-P / Serena Quadripolar CRT-P, So (P010015/S345) | Medtronic, Inc. | 2017-11-13 |
| Edwards Commander Delivery System (P140031/S056) | Edwards Lifesciences, LLC | 2017-11-13 |
| Revo MRI SureScan IPG (P090013/S264) | Medtronic, Inc. | 2017-11-13 |
| Advisa DR IPG / DR MRI IPG/ SR MRI IPG; Astra XT DR MRI IPG / S DR MRI IPG / S SR MRI IPG/ XT SR MRI IPG; AZURA S DR MRI (P980035/S523) | Medtronic, Inc. | 2017-11-13 |
| Assurity MRI and Endurity MRI family of Pacemakers, (P140033/S017) | ABBOTT MEDICAL | 2017-11-09 |
| Microny family of Pacemakers (P970013/S075) | ABBOTT MEDICAL | 2017-11-09 |
| Epic Vascular Self-Expanding Stent System (P110035/S042) | Boston Scientific Corp | 2017-11-09 |
| Medtronic Attain Ability Model 4196 (P080006/S114) | Medtronic, Inc. | 2017-11-09 |
| CapSure Epicardial Pacing Lead (P950024/S076) | Medtronic, Inc. | 2017-11-09 |
| Innova Self-Expanding Stent System (P140028/S029) | Boston Scientific Corporation | 2017-11-09 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S177) | Medtronic, Inc. | 2017-11-09 |
| Anthem, Allure/RF,Allura Quadra/RF family of CRT-Ps (P030035/S162) | ABBOTT MEDICAL | 2017-11-09 |
| Epic Vascular Self-Expanding Stent System (P110035/S043) | Boston Scientific Corp | 2017-11-09 |
| CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead (P830061/S151) | Medtronic Cardiac Rhythm Disease Management | 2017-11-09 |
| Promote/+/RF/Q. Promote Accel, Promote Quadra, Unity, Unity Assura, Unity Quadra, Quadra Assura , Epic+/HF/HF+/ II HF, A (P030054/S340) | ABBOTT MEDICAL | 2017-11-09 |
| CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S382) | Medtronic, Inc. | 2017-11-09 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S290) | ABBOTT MEDICAL | 2017-11-09 |
| CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S128) | Medtronic Cardiac Rhythm Disease Management | 2017-11-09 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+ familyof ICD's (P910023/S396) | ABBOTT MEDICAL | 2017-11-09 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Ellipse (P030054/S339) | ABBOTT MEDICAL | 2017-11-08 |
| Assurity MRI, Endurity MRI (P140033/S016) | ABBOTT MEDICAL | 2017-11-08 |
| Siello S and Solia S, EFH-6F-W and DH IS-1/DF4 (P950037/S181) | Biotronik, Inc. | 2017-11-08 |
| Accent, Assurity, Endurity, Verity ADx, Zephyr, Identity ADx, Victory (P880086/S289) | ABBOTT MEDICAL | 2017-11-08 |
| Anthem, Allure/Allure RF, Allure Quadra / Allure Quadra RF, Allure Quadra MP RF (P030035/S161) | ABBOTT MEDICAL | 2017-11-08 |
| Microny (P970013/S074) | ABBOTT MEDICAL | 2017-11-08 |
| Fortify, Fortify Assura, Quadra Assura, Ellipse (P910023/S395) | ABBOTT MEDICAL | 2017-11-08 |