| Cardiac Resynchronization Therapy Pacemaker Models Invive & Intua (P030005/S153) | Guidant Corp. | 2017-05-01 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S325) | Medtronic, Inc. | 2017-04-28 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Max (P980016/S629) | Medtronic Cardiac Rhythm Disease Management | 2017-04-28 |
| RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P160043) | Medtronic Vascular | 2017-04-28 |
| 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/S589) | Medtronic Cardiac Rhythm Disease Management | 2017-04-28 |
| Micra TPS (P150033/S022) | Medtronic, Inc. | 2017-04-28 |
| Adapta, Versa, Sensia IPG; Advisa DR IPG,Advisa DR MRI IPG, Advisa SR MRI IPG, Relia IPG (P980035/S494) | Medtronic, Inc. | 2017-04-28 |
| MitraClip Delivery System (P100009/S023) | ABBOTT MEDICAL | 2017-04-28 |
| Revo MRI SureScan IPG (P090013/S253) | Medtronic, Inc. | 2017-04-28 |
| AngioJet Ultra Thrombecomy System Conosle (P980037/S064) | Boston Scientific Corp | 2017-04-27 |
| Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01 (P010015/S326) | Medtronic, Inc. | 2017-04-26 |
| Evera, Visia MRI ICD, S VR ICD, XT VR ICD (P980016/S628) | Medtronic Cardiac Rhythm Disease Management | 2017-04-26 |
| Amplia, Amplia MRI Quad, Brava, Brava MRI Quad, Claria MRI, Compia, Viva XT CRT-D (P010031/S588) | Medtronic Cardiac Rhythm Disease Management | 2017-04-26 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-D (P010015/S324) | Medtronic, Inc. | 2017-04-26 |
| Advisia DR IPG, Advisia DR/SR MRI IPG (P980035/S493) | Medtronic, Inc. | 2017-04-26 |
| Micra TPS (P150033/S021) | Medtronic, Inc. | 2017-04-26 |
| Revo MRI SureScan IPG RVDR01 (P090013/S255) | Medtronic, Inc. | 2017-04-26 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S018) | Medinol, Ltd. | 2017-04-26 |
| Revo MRI SureScan IPG (P090013/S252) | Medtronic, Inc. | 2017-04-26 |
| Advisa DR IPG A4DR01; Advisa DR MRI IPG A2DR01; Advisa SR MRI IPG A3SR01 (P980035/S496) | Medtronic, Inc. | 2017-04-26 |
| XIENCE PRIME Everolimus Eluting Coronary Stent System, SV, LL (P110019/S092) | Abbott Vascular | 2017-04-25 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 3000, 3100, 4000. (P010030/S086) | Zoll Manufacturing Corporation | 2017-04-25 |
| SPRINT QUATTRO MRI SURESCAN LEAD MODEL 6946M (P920015/S196) | Medtronic, Inc. | 2017-04-25 |
| Attain Ability MRI / Plus / Straight SureScan Leads; Attain Performa MRI / Straight / S MRI SureScan Leads (P080006/S101) | Medtronic, Inc. | 2017-04-25 |
| AMPLIA MRI AND AMPLIA MRI QUAD CRT-D SURESCAN MODELS DTMB1D4, DTMB1QQ. COMPIA MRI, CLARIA MRI (P010031/S577) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| EVERA MRI XT DR SURESCAN MODELS DDMB1D4, EVERA MRI ST VR SURESCAN MODEL DVMB1D4, VISIA AF MRI VR SURESCAN DVFC3D4 IMPLAN (P980016/S618) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| Revo MRI SureScan IPG & CapSureFix MRI SureScan Lead MRI (P090013/S240) | Medtronic, Inc. | 2017-04-25 |
| SELECTSECURE MRI SURESCAN LEAD MODEL 3830 (P030036/S093) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| CAPSURE FIX NOVUS MRI SURESCAN LEAD MODELS 5076 AND 4076 (P930039/S168) | Medtronic, Inc. | 2017-04-25 |
| 4598MEDTRONIC ATTAIN ABILITY MODEL 4196, ATTAIN PERFORMA S MRI SURESCAN LEAD MODEL (P080006/S107) | Medtronic, Inc. | 2017-04-25 |
| MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036/S088) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| Amplia MRI and Amplia MRI Quad CRT-D SureScan , Compia MRI and Compia MRI Quad CRT-D SureScan, Claria MRI and Claria MRI (P010031/S569) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| Advisa MRI DR /SR SureScan Implantable Pulse Generators (IPGs) (P980035/S481) | Medtronic, Inc. | 2017-04-25 |
| CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI (P090013/S248) | Medtronic, Inc. | 2017-04-25 |
| Sprint Quattro Secure S MRI & MRI SureScan Leads (P920015/S188) | Medtronic, Inc. | 2017-04-25 |
| CAPSURE SENSE MRI SURESCAN LEAD MODEL 4574 (P830061/S143) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| CapSure Sense MRI SureScan Leads (P830061/S137) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| Evera MRI XT DR /VR SureScan; Evera MRI S DR/VR SureScan; Visia AF MRI XT Surescan; Visia AF MRI S VR Surescan DVFC3D4 A (P980016/S609) | Medtronic Cardiac Rhythm Disease Management | 2017-04-25 |
| XIENCE V Everolimus Eluting Coronary Stent System (P070015/S136) | Abbott Vascular, Inc. | 2017-04-25 |
| CapSureFix Novus MRI SureScan Lead (P930039/S162) | Medtronic, Inc. | 2017-04-25 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S041) | ABBOTT MEDICAL | 2017-04-24 |
| ECLA GlideLight Catheter (P910001/S092) | Spectranetics Corp. | 2017-04-24 |
| ELCA and SLS/GlideLight Catheter (P960042/S056) | Spectranetics (Philips) | 2017-04-24 |
| LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT (P160024) | Bard Peripheral Vascular, Inc. | 2017-04-24 |
| Evera MRI DF-1/Evera MRI/Evera S DR/Evera S VR/Evera XT DR/Evera XT VR/Maximo II/Protecta/Protecta VR/Protecta XT/Secura (P980016/S630) | Medtronic Cardiac Rhythm Disease Management | 2017-04-23 |
| All Flex 4-Socket Hi-POT/Pulse Test System (P110042/S082) | Boston Scientific Corporation | 2017-04-23 |
| Amplia MRI/Amplia MRI Quad/Brava/Brava Quad/Claria MRI/Claria MRI Quad/Compia MRI/Compai MRI Quad/Consulta/Maximo II/Pro (P010031/S590) | Medtronic Cardiac Rhythm Disease Management | 2017-04-23 |
| Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen CRT-D Resynchronization Devices (P010012/S445) | Boston Scientific Corp | 2017-04-21 |
| LATITUDE NXT Patient Management System/ LATITUDE NXT G2 Communicator (P910077/S158) | Boston Scientific | 2017-04-21 |
| Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen ICD Devices (P960040/S389) | Boston Scientific | 2017-04-21 |
| Micra Transcatheter Pacing System (P150033/S018) | Medtronic, Inc. | 2017-04-21 |
| Arctic Front and Arctic Front Advance Cardiac CryoAlbation Catheters (P100010/S064) | Medtronic Cryocath, LP | 2017-04-21 |
| NovaFlex+ Delivery System (P130009/S072) | Edwards Lifesciences, LLC | 2017-04-20 |
| Medtronic CoreValve and Medtronic Evolut Systems (P130021/S037) | Medtronic, Inc. | 2017-04-20 |
| MetriQ Irrigation Pump (P150005/S013) | Boston Scientific Corp | 2017-04-20 |
| ACUITY X4 Lead (P910073/S141) | Boston Scientific | 2017-04-19 |
| FINELINE II Sterox and Sterox EZ Lead (P960004/S079) | Boston Scientific | 2017-04-19 |
| ENDOTAK RELIANCE IS-1 and ENDOTAK RELIANCE 4-SITE Lead (P010012/S447) | Boston Scientific Corp | 2017-04-19 |
| Edwards Commander Delivery System (P140031/S037) | Edwards Lifesciences, LLC | 2017-04-19 |
| INGEVITY Lead (P150012/S027) | Boston Scientific | 2017-04-19 |
| AngioSculpt RX PTCA Scoring Balloon Catheter (P050018/S024) | Spectranetics Corp. | 2017-04-17 |
| LATITUDE NXT Release 5.0 (P910077/S156) | Boston Scientific | 2017-04-17 |
| Arctic Front Family of Catheters (P100010/S063) | Medtronic Cryocath, LP | 2017-04-17 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA ICD's (P960040/S384) | Boston Scientific | 2017-04-17 |
| Freezer Cardiac Cryoablation, Freezer Xtra Surgical Cardiac, Freezer MAX Surgical Cardiac (P020045/S082) | Medtronic Cryocath, LP | 2017-04-17 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA AND ALTRUA 2 PACEMAKER's (N970003/S197) | Boston Scientific Corp | 2017-04-17 |
| FlexAbility Ablation Catheter, Sensor Enabled (Bi-Directional) & FlexAbility Ablation Catheter, Sensor Enabled (Uni-Dire (P110016/S040) | ABBOTT MEDICAL | 2017-04-17 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT CRT-D's Resynchroniza (P010012/S435) | Boston Scientific Corp | 2017-04-17 |
| INVIVE, INTUA, VISIONIST, VALITUDE CRT-P's Resynchronization Devoces (P030005/S145) | Guidant Corp. | 2017-04-17 |
| EMBLEM SUBCUTANEOUS ICD's (P110042/S068) | Boston Scientific Corporation | 2017-04-17 |
| Impella Ventricular Support Systems (P140003/S016) | Abiomed, Inc. | 2017-04-17 |
| IMPELLA 2.5 SYSTEM (P140003/S014) | Abiomed, Inc. | 2017-04-14 |
| 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 M (P010031/S583) | Medtronic Cardiac Rhythm Disease Management | 2017-04-14 |
| Absolute Pro Vascular Self-Expanding Stent System. (P110028/S017) | Abbott Vascular, Inc. | 2017-04-14 |
| Evera MRI DF-I ICD/Evera MRI ICD/ Evera S DR ICD/Evera S VR ICD/ Evera XT DR ICD/ Evera XT VR ICD/ Visia AF MRI DF1 ICD/ (P980016/S624) | Medtronic Cardiac Rhythm Disease Management | 2017-04-14 |
| EMBLEM S-ICD Model A209; EMBLEM MRI S-ICD Model A219 (P110042/S081) | Boston Scientific Corporation | 2017-04-13 |
| MitraClip NT Clip Delivery System (P100009/S022) | ABBOTT MEDICAL | 2017-04-13 |
| Enroute Transcarotid Stent System (P140026/S006) | Boston Scientific Corporation | 2017-04-13 |
| WATCHMAN Left Atrial Appendage Closure Technology (P130013/S013) | Boston Scientific Corp | 2017-04-13 |
| Medtronic CoreValve Evolut R Transcather Aortic Valve(bioprosthesis); EnVeo R Delivery Catheter System; EnVeo R Loading (P130021/S036) | Medtronic, Inc. | 2017-04-13 |
| Medtronic Cardiac Rhythm and Heart Failure (P010031/S587) | Medtronic Cardiac Rhythm Disease Management | 2017-04-12 |
| Amplia MRI CRT-D, Claria MRI CRT-D, Compia MRI CRT-D (P010031/S584) | Medtronic Cardiac Rhythm Disease Management | 2017-04-12 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S627) | Medtronic Cardiac Rhythm Disease Management | 2017-04-12 |
| Medtronic Vascular Endurant Stent Graft System (P100021/S062) | Medtronic Vascular | 2017-04-12 |
| Synergy Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and Over-the-Wire. (P150003/S028) | Boston Scientific Corporation | 2017-04-11 |
| MEDTRONIC COREVALVE(TM) EVOLUT(TM) R SYSTEM (P130021/S028) | Medtronic, Inc. | 2017-04-11 |
| HeartMate II LVAS (P060040/S066) | ABBOTT MEDICAL | 2017-04-11 |
| Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, Advisa SR MRI, Relia IPG (P980035/S492) | Medtronic, Inc. | 2017-04-11 |
| Consulta, Syncra, Viva CRT-P (P010015/S323) | Medtronic, Inc. | 2017-04-11 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S024) | Cook Ireland, Ltd. | 2017-04-11 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S139) | Boston Scientific Corp | 2017-04-11 |
| ESSENTIO, PROPONENT, ACCOLADE, INGEVITY MRI'S & SLIT SUTURE SLEEVE ACCESSORY (FOR INGEVITY MRI LEADS) (P150012/S021) | Boston Scientific | 2017-04-11 |
| VASCADE 6/7f VCS & VASCADE 5F VCS (P120016/S023) | Cardiva Medical, Inc. | 2017-04-11 |
| FINELINE II STEROX & FINELINE II STEROX EZ, SUTURE SLEEVE ACCESSORY(FOR FINELINE II LEADS) (P960004/S078) | Boston Scientific | 2017-04-11 |
| FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled (P110016/S039) | ABBOTT MEDICAL | 2017-04-10 |
| IntellaNav Open Irrigated Ablation Catheter (P150005/S018) | Boston Scientific Corp | 2017-04-07 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S036) | Edwards Lifesciences, LLC | 2017-04-07 |
| Rx Acculink Carotid Stent System (P040012/S059) | Abbott Vascular | 2017-04-07 |
| INNOVA(TM)VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S021) | Boston Scientific Corporation | 2017-04-07 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S071) | Edwards Lifesciences, LLC | 2017-04-07 |