| Evera/MRI/DF, ICD, S DR, XT DR, S VR, XT VR, Maximo II ICD, Secura DR ICD/ DR, Visia AF MRI DFI ICD/VR ICD (P980016/S637) | Medtronic Cardiac Rhythm Disease Management | 2017-07-18 |
| IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S620) | Medtronic Cardiac Rhythm Disease Management | 2017-07-18 |
| IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S579) | Medtronic Cardiac Rhythm Disease Management | 2017-07-18 |
| Carpentier-Edwards® PERIMOUNT® Pericardial/RSR/Magna/Magna Ease Aortic/ Plus/ Theon Pericardial Mitral Bioprosthesis wit (P860057/S164) | Edwards Lifesciences, LLC | 2017-07-18 |
| CapSure Sense Lead/ CapSure SP Novus Lead/Vitatron Crystalline Lead (P830061/S147) | Medtronic Cardiac Rhythm Disease Management | 2017-07-18 |
| CapSureFix Lead/ CapSureFix Novus Lead/ Vitatron Crystalline Active Fixation Lead (P930039/S173) | Medtronic, Inc. | 2017-07-18 |
| Revo MRI SureScan IPG (P090013/S261) | Medtronic, Inc. | 2017-07-18 |
| Consulta, Percept Bipolar, Percepta Quadripolar, Serena Bipolar/Quadripolar, Syncra, Viva CRT-P (P010015/S336) | Medtronic, Inc. | 2017-07-18 |
| Attain Bipolar OTW Lead; Attain OTW LV Lead (P010015/S335) | Medtronic, Inc. | 2017-07-18 |
| Transvene CS/SVC Lead (P980050/S111) | Medtronic, Inc. | 2017-07-18 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S078) | Edwards Lifesciences, LLC | 2017-07-18 |
| EDWARDS INTUITY Valve System (P150036/S013) | Edwards Lifesciences, LLC | 2017-07-18 |
| WEBSTER CATHETER; CELSIUS THERMOCOOL CATHETER; CELSIUS CATHETER;; CELSIUS RMT CATHETER (P950005/S063) | Biosense Webster, Inc. | 2017-07-17 |
| NAVISTAR RMT; NAVISTAR RMT DS CATHETER (P990025/S051) | Biosense Webster, Inc. | 2017-07-17 |
| Medtronic CoreValve System/ Evolut R System/ Evolut PRO System (P130021/S039) | Medtronic, Inc. | 2017-07-17 |
| Supera Peripheral Stent System (P120020/S016) | Abbott Vascular (Idef Technologies Inc) | 2017-07-14 |
| Impella Ventricular Support Systems (P140003/S021) | Abiomed, Inc. | 2017-07-14 |
| VenaSeal Closure System (P140018/S007) | Medtronic Vascular, Inc. | 2017-07-13 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S048) | Best Vascular, Inc. | 2017-07-13 |
| TRYTON Side Branch Stent (P150039/S001) | Poseidon Medical, Inc. | 2017-07-13 |
| Adapta, Versa Sensia IPG Relia IPG (P980035/S510) | Medtronic, Inc. | 2017-07-12 |
| Excluder AAA Endoprosthesis (P020004/S145) | W. L. Gore & Associates, Inc. | 2017-07-11 |
| CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System (P130021/S033) | Medtronic, Inc. | 2017-07-10 |
| Spectranetics CVX-300 Exclimer Laser System (P910001/S091) | Spectranetics Corp. | 2017-07-07 |
| Model 2889 EMBLEM S-ICD Automated Screening Tool, v1.01 (P110042/S067) | Boston Scientific Corporation | 2017-07-06 |
| TRIDYNE VASCULAR SEALANT (P150016/S005) | Neomend, Inc. | 2017-07-06 |
| MULTIPLE APPLICATION UTILITY MODEL 2909 (FROM V9.03 TO V9.04) (P910077/S155) | Boston Scientific | 2017-07-06 |
| Micra Transcatheter Pacing System (P150033/S024) | Medtronic, Inc. | 2017-07-05 |
| CapSure Epicardial Pacing Lead (P950024/S074) | Medtronic, Inc. | 2017-07-05 |
| Subcutaneous Lead, Transvene CS/SVC Lead (P920015/S200) | Medtronic, Inc. | 2017-07-05 |
| CapSure SP/Z Novus Lead, Vitatron Excellence SS+/Impulse II Lead (P850089/S126) | Medtronic Cardiac Rhythm Disease Management | 2017-07-05 |
| CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S376) | Medtronic, Inc. | 2017-07-05 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S148) | Medtronic Cardiac Rhythm Disease Management | 2017-07-05 |
| Attain Ability/Performa Lead (P080006/S112) | Medtronic, Inc. | 2017-07-05 |
| Myocardial Pacing Lead (P120017/S009) | Medtronic, Inc. | 2017-07-05 |
| Rotational Atherectomy System (P900056/S157) | Boston Scientific Corp | 2017-07-05 |
| IN PACT Admiral Paclitarel-Coated Balloon Catheter (P140010/S032) | Medtronic, Inc. | 2017-07-05 |
| Transvene CS/SVC Lead (P980050/S112) | Medtronic, Inc. | 2017-07-05 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation/Pirouet Lead (P930039/S174) | Medtronic, Inc. | 2017-07-05 |
| Wallstent (Venous) Endoprosthesis with unistep plus delivery system (P980033/S049) | Boston Scientific Corporation | 2017-07-03 |
| Wallstent Illiac Endoprosthesis with unistep plus delivery system (P940019/S051) | Boston Scientific Scimed, Inc. | 2017-07-03 |
| Carotid Wallstent Monorail Endoprothesis plus delivery system (P050019/S028) | Boston Scientific Corp | 2017-07-03 |
| Wallstent (Tips) Endoprosthesis with unistep plus delivery system (P930031/S060) | Boston Scientific Corp | 2017-07-03 |
| EASYTRACK 2 Lead, ACUITY Spiral Lead (P010012/S456) | Boston Scientific Corp | 2017-06-30 |
| Hanock II Bioprosthesis, Models T505 and T510 (P980043/S059) | Medtronic, Inc. | 2017-06-30 |
| Mosaic Bioprosthesis, Models 305 and 310 (P990064/S068) | Medtronic, Inc. | 2017-06-30 |
| FINELINE II Lead (P960040/S397) | Boston Scientific | 2017-06-30 |
| ENDOTAK RELIANCE IS-1 LEAD (P910073/S143) | Boston Scientific | 2017-06-30 |
| HEARTMATE II LVAS (P060040/S065) | ABBOTT MEDICAL | 2017-06-30 |
| Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators (P980016/S635) | Medtronic Cardiac Rhythm Disease Management | 2017-06-30 |
| Concerto/Insync Sentry/Insync Maximo Implantable Cardiovascular Defibrillators with Cardiac Resynchicnization (P010031/S596) | Medtronic Cardiac Rhythm Disease Management | 2017-06-30 |
| EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) (P150048) | Edwards Lifesciences, LLC | 2017-06-29 |
| HeartWare Ventricular Assist Device System (P100047/S100) | Medtronic | 2017-06-29 |
| Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System (P980033/S048) | Boston Scientific Corporation | 2017-06-28 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (P040044/S075) | Cordis US Corporation | 2017-06-28 |
| CapSureFix MRI Lead 5086MRI (P090013/S258) | Medtronic, Inc. | 2017-06-28 |
| Wallstent (Tips) Endoprosthesis With Unistep Plus Delivery System (P930031/S059) | Boston Scientific Corp | 2017-06-28 |
| ASTRA S DR MRI IPG X3DR01, ASTRA S SR MRI IPG X3SR01, ASTRA XT DR MRI IPG X1DR01, ASTRA XT SR MRI IPG X1SR01 (P980035/S509) | Medtronic, Inc. | 2017-06-28 |
| EnVeo R Delivery Catheter System (P130021/S038) | Medtronic, Inc. | 2017-06-28 |
| Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRT-P W1TR02, Serena Quadripolar CRT-P (P010015/S334) | Medtronic, Inc. | 2017-06-28 |
| CapSureFix Novus Lead 4076, 5076 - Vitatron Crystalline Active Fixation Lead ICF09, ICF09B, ICFQ09B (P930039/S171) | Medtronic, Inc. | 2017-06-28 |
| Wallstent Lilac Endoprosthesis With Unistep Plus Delivery System (P940019/S050) | Boston Scientific Scimed, Inc. | 2017-06-28 |
| HeartWare Ventricular Assist System (P100047/S095) | Medtronic | 2017-06-27 |
| IntellaNav XP and IntellaNav MiFi XP Temperature Ablation Catheters (P020025/S102) | Boston Scientific | 2017-06-27 |
| CELT ACD VASCULAR CLOSURE DEVICE (P150006/S001) | Vasorum, Ltd. | 2017-06-27 |
| HeartWare Ventricular Assist Device System (P100047/S097) | Medtronic | 2017-06-27 |
| HeartWare Ventricular Assist System (P100047/S098) | Medtronic | 2017-06-27 |
| Contak CD,Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S455) | Boston Scientific Corp | 2017-06-26 |
| XIENCE PRIME SV/LL Everolimus Eluting Coronary Stent System (P110019/S093) | Abbott Vascular | 2017-06-23 |
| Absorb GTi Bioresorbable Vascular Scaffold (BVS) System (P150023/S009) | Abbott Vascular, Inc. | 2017-06-23 |
| RF Filter Module (P020025/S095) | Boston Scientific | 2017-06-23 |
| XIENCE V/nano Everolimus Eluting Coronary Stent System (P070015/S137) | Abbott Vascular, Inc. | 2017-06-23 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S059) | ABBOTT MEDICAL | 2017-06-23 |
| Siello S 45, S53, S60 / Solia S 45, S53, S 60 (P950037/S178) | Biotronik, Inc. | 2017-06-23 |
| MyCareLink and MyCareLink Smart Patient Monitor (P890003/S373) | Medtronic, Inc. | 2017-06-23 |
| IN.Pact Admiral Paclitaxel-Coated Ballon Catheter (P140010/S034) | Medtronic, Inc. | 2017-06-23 |
| Sapien XT Transcatheter Heart Valve (P130009/S077) | Edwards Lifesciences, LLC | 2017-06-22 |
| CapSure SP Novus/CapSure SP Z/CapSure Z Novus/Vitatron Impulse II Lead (P850089/S124) | Medtronic Cardiac Rhythm Disease Management | 2017-06-22 |
| Y Adaptor/Extender Kit/DF-1 Connector Port Pin Plug/HV splitter/adaptor kit/Lead Adaptor/Sprint Quattro Lead/Subcutaneou (P920015/S198) | Medtronic, Inc. | 2017-06-22 |
| Amplia MRI/Amplia MRI Quad;Brava/Brava Quad; Claria MRI/Claria MRI Quad; Compia MRI/Compia MRI Quad; Consulta; Maximo II (P010031/S597) | Medtronic Cardiac Rhythm Disease Management | 2017-06-22 |
| CapSureFix/CapSureFix Novus/Vitatron Crystalline Active Fixation Lead (P930039/S172) | Medtronic, Inc. | 2017-06-22 |
| CapSure Epicardial Pacing Lead (P950024/S073) | Medtronic, Inc. | 2017-06-22 |
| Adapta, Versa, Sensia/Advisa DR/Advisa DR MRI/Advisa SR MRI/ASTRA S DR MRI/ASTRA S SR MRI/ASTRA XT DR MRI/ASTRA XT SR MR (P980035/S508) | Medtronic, Inc. | 2017-06-22 |
| Transvene CS/SVC Lead (P980050/S110) | Medtronic, Inc. | 2017-06-22 |
| Attain StarFix Lead (P060039/S078) | Medtronic, Inc. | 2017-06-22 |
| Attain Bipolar OTW/Attain OTW LV Lead; Consulta/Percepta Bipolar/Percepta Quadripolar/Serena Bipolar/Serena Quadripolar/ (P010015/S333) | Medtronic, Inc. | 2017-06-22 |
| 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/S636) | Medtronic Cardiac Rhythm Disease Management | 2017-06-22 |
| CapSureFix MRI Lead/ Revo MRI SureScan IPG (P090013/S259) | Medtronic, Inc. | 2017-06-22 |
| MitraClip and MitraClip NT Clip Delivery System (P100009/S024) | ABBOTT MEDICAL | 2017-06-22 |
| CapSure Sense/CapSure SP/CapSure SP Novus/CapSureSense/Vitatron Crystalline Lead (P830061/S146) | Medtronic Cardiac Rhythm Disease Management | 2017-06-22 |
| Sapien 3 Transcatheter Heart Valve (P140031/S043) | Edwards Lifesciences, LLC | 2017-06-22 |
| Epicardial Patch Lead/Upsizing Sleeve (P900061/S146) | Medtronic Cardiac Rhythm Disease Management | 2017-06-22 |
| Myocardial Pacing Lead (P120017/S008) | Medtronic, Inc. | 2017-06-22 |
| Attain Ability/Performa Lead (P080006/S109) | Medtronic, Inc. | 2017-06-22 |
| HeartWare Ventricular Assist System (P100047/S094) | Medtronic | 2017-06-21 |
| Implantable Cardioverter Defibrillator (ICD) - Origen: D000, D001, D002, D003, D050, D051, D052, D053 - Inogen: D010, D0 (P960040/S394) | Boston Scientific | 2017-06-21 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) - Origne: G050, G051, G056, G058 - Inogen: G140, G141, G146, G14 (P010012/S451) | Boston Scientific Corp | 2017-06-21 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S002) | Medtronic Vascular | 2017-06-21 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S079) | Medtronic Vascular | 2017-06-21 |
| Stockert 70 RF Generator Foot Pedal (P990071/S035) | Biosense Webster, Inc. | 2017-06-21 |