| CONSULTA CRT-P, SYNERA CRT-P, VIVA CRT-P (P010015/S261) | Medtronic, Inc. | 2015-02-23 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S414) | Medtronic, Inc. | 2015-02-23 |
| ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S408) | Medtronic, Inc. | 2015-02-23 |
| EVERA S DR ICD,VR ICD, XT DR ICD,VR ICD, MAXIMO II ICD, PROTECTA ICD,XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S529) | Medtronic Cardiac Rhythm Disease Management | 2015-02-23 |
| EVERA S DR, VR,; EVERA XT DR, EVERA XT VR , MAXIMO II , PROTECTA , PROTECTA XT, SECURA; AND VIRTUOSO II D/RVR ICD'S (P980016/S523) | Medtronic Cardiac Rhythm Disease Management | 2015-02-23 |
| REVO MRI IPG (P090013/S171) | Medtronic, Inc. | 2015-02-23 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II D (P980016/S524) | Medtronic Cardiac Rhythm Disease Management | 2015-02-23 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S266) | Medtronic, Inc. | 2015-02-23 |
| REVO MRI IPG (P090013/S176) | Medtronic, Inc. | 2015-02-23 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S260) | Medtronic, Inc. | 2015-02-23 |
| DYNAGEN, INOGEN, ORIGEBN, PUNCTUA,ENERGEN, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S342) | Boston Scientific | 2015-02-23 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S058) | Zoll Manufacturing Corporation | 2015-02-22 |
| VENASEAL CLOSURE SYSTEM (P140018) | Medtronic Vascular, Inc. | 2015-02-20 |
| SELOX JT 45 /JT53; ST53/ST60;TILDA R45, R53,R60; SAFIO S53, S60; TILDA JT45,53, TILDA T53,60; DRUG ELUTING PERMANENT RIG (P950037/S147) | Biotronik, Inc. | 2015-02-20 |
| LINOX SMART SD60/16; SD 65/16; 65/18, 75/18; S60, S65, S75, S DX 65/15, 65/17, T65, TD 65/16, 65/18, VOLTA TA ICR60,65,7 (P980023/S064) | Biotronik, Inc. | 2015-02-20 |
| CELERITY 2D 75, 2D 85, 3D75, 3D85, PIOLOT 75,85; COROX OTW 75-UP STEROID, 85-UP, 85-BP, D75-BP (P070008/S059) | Biotronik, Inc. | 2015-02-20 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S407) | Medtronic, Inc. | 2015-02-19 |
| GORE HELEX EX SEPTAL OCCLUDER (P050006/S045) | W. L. Gore & Associates, Inc. | 2015-02-19 |
| REVO MRI IPG (P090013/S170) | Medtronic, Inc. | 2015-02-19 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II (P980016/S520) | Medtronic Cardiac Rhythm Disease Management | 2015-02-19 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S259) | Medtronic, Inc. | 2015-02-19 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD S (P010031/S484) | Medtronic Cardiac Rhythm Disease Management | 2015-02-19 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S094) | ABBOTT MEDICAL | 2015-02-19 |
| CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILES OF ICD DEVICES (P910023/S353) | ABBOTT MEDICAL | 2015-02-18 |
| PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILES OF CRT-D DEVICES (P030054/S282) | ABBOTT MEDICAL | 2015-02-18 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S026) | Edwards Lifesciences, LLC | 2015-02-13 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S038) | ABBOTT MEDICAL | 2015-02-12 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S030) | Syncardia Systems, LLC | 2015-02-12 |
| TRIFECTA VALVE (P100029/S019) | ABBOTT MEDICAL | 2015-02-12 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S002) | Cardiovascular Systems, Inc. | 2015-02-12 |
| BIOCOR, EPIC AND EPIC SUPRA VALVE (P040021/S026) | ABBOTT MEDICAL | 2015-02-12 |
| REVO MRI IPG (P090013/S169) | Medtronic, Inc. | 2015-02-12 |
| ADAPTA, VERSA, SENSIA IPGS, ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S406) | Medtronic, Inc. | 2015-02-12 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S006) | AtriCure, Inc. | 2015-02-12 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S519) | Medtronic Cardiac Rhythm Disease Management | 2015-02-12 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S483) | Medtronic Cardiac Rhythm Disease Management | 2015-02-12 |
| ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS. (P930029/S049) | Medtronic, Inc. | 2015-02-12 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S024) | Edwards Lifesciences, LLC | 2015-02-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S063) | Edwards Lifesciences, LLC | 2015-02-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, WITH THERMAFIX TISSUE PROCESS, RSR PERICARDIAL AORTIC BIO (P860057/S132) | Edwards Lifesciences, LLC | 2015-02-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S050) | Edwards Lifesciences, LLC | 2015-02-11 |
| REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES (P810002/S093) | ABBOTT MEDICAL | 2015-02-10 |
| IPERIA FAMILY ICD/CRT-D: IPERIA ITREVIA AND INVENTRA (P050023/S079) | Biotronik, Inc. | 2015-02-10 |
| REVO MRI IPG (P090013/S166) | Medtronic, Inc. | 2015-02-10 |
| DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM (P950037/S139) | Biotronik, Inc. | 2015-02-10 |
| CONSULTA CRT-P, SYNERA CRT-P, VIVA CRT-P (P010015/S257) | Medtronic, Inc. | 2015-02-09 |
| EVERA S DR ICD; VR ICD, EVERTA XT DR ICD; EVERA XT VR ICD, MAXIMO II ICD; PROTECTA ICD, PROTECTA XT ICD , SECURA ICD; VI (P980016/S516) | Medtronic Cardiac Rhythm Disease Management | 2015-02-09 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S029) | Boston Scientific Corp | 2015-02-09 |
| BRAVA CRT-D'S; BRAVA QUAD CRT-D'S; CONCERTO II CRT-D; CONSULTA CRT-D; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRT (P010031/S480) | Medtronic Cardiac Rhythm Disease Management | 2015-02-09 |
| ON-X PROSTHETIC HEART VALVE (P000037/S037) | On-X Life Technologies, Inc. | 2015-02-09 |
| ADAOTA, VERSA, SENSIA IPG, ADVISSA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S405) | Medtronic, Inc. | 2015-02-07 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S124) | Medtronic, Inc. | 2015-02-07 |
| CAPSUREFIX MRI LEAD (P090013/S168) | Medtronic, Inc. | 2015-02-07 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S481) | Medtronic Cardiac Rhythm Disease Management | 2015-02-07 |
| BRAVA CRT-D, BRAVA QUARD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD (P010031/S482) | Medtronic Cardiac Rhythm Disease Management | 2015-02-07 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA XT ICD, PROTECTA XT ICD, SECUR (P980016/S518) | Medtronic Cardiac Rhythm Disease Management | 2015-02-07 |
| REVO MRI IPG (P090013/S167) | Medtronic, Inc. | 2015-02-07 |
| SELECTSECURE LEAD (P030036/S076) | Medtronic Cardiac Rhythm Disease Management | 2015-02-07 |
| SPRINT QUATTRO LEAD, SPRINT QUATTRO LEAD (P920015/S147) | Medtronic, Inc. | 2015-02-07 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S258) | Medtronic, Inc. | 2015-02-07 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S517) | Medtronic Cardiac Rhythm Disease Management | 2015-02-07 |
| MULTI-LINK ULTRA CORONARY STENT SYSTEMS (P970020/S081) | Abbott Vascular, Inc. | 2015-02-06 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S127) | Abbott Vascular, Inc. | 2015-02-06 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS,XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS,XIENCE (P110019/S074) | Abbott Vascular | 2015-02-06 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S054) | Abbott Vascular | 2015-02-06 |
| ABSOLUTE PRO VASCULAR STENT SYSTEMS (P110028/S014) | Abbott Vascular, Inc. | 2015-02-06 |
| MULTI-LINK VISION,MULTI-LINK MINI VISION,MULTI-LINK 8 CORONARY STENT SYSTEMS (P020047/S061) | Abbott Vascular | 2015-02-06 |
| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM (P910001/S077) | Spectranetics Corp. | 2015-02-05 |
| EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S023) | Edwards Lifesciences, LLC | 2015-02-05 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S113) | Boston Scientific Corp | 2015-02-04 |
| FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE (P950020/S071) | Boston Scientific Corp | 2015-02-04 |
| AORFIX AND AORFIX PLUS AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE (P110032/S010) | Lombard Medical Limited | 2015-02-03 |
| TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION IX ILIAC STENT GRAFT (P120006/S015) | Endologix, LLC | 2015-02-02 |
| CONSULTA CRT-P, SYNERA CRT-P, VIVA CRT-P (P010015/S256) | Medtronic, Inc. | 2015-02-02 |
| DEXTRUS, SETROX S, TILDA, SAFIO S (P950037/S146) | Biotronik, Inc. | 2015-02-02 |
| LINOX SMART SD, LINOX SMART S, VOLTA 1CR, VOLTA 2CR (P980023/S063) | Biotronik, Inc. | 2015-02-02 |
| LIVEWIRE TC ABLATION CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER (P960016/S051) | St Jude Medical | 2015-02-02 |
| EDWARDS SAPIEN CT TRANSCATHETER HEART VALVE (P130009/S022) | Edwards Lifesciences, LLC | 2015-01-30 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S049) | Edwards Lifesciences, LLC | 2015-01-30 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S131) | Edwards Lifesciences, LLC | 2015-01-30 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S062) | Edwards Lifesciences, LLC | 2015-01-30 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO I (P980016/S513) | Medtronic Cardiac Rhythm Disease Management | 2015-01-30 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO 11 CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, PROTECTA XT CRT-D, (P010031/S477) | Medtronic Cardiac Rhythm Disease Management | 2015-01-30 |
| NG3 FAMILY OF CRT-D'S (ORIGEN, INOGEN, & DYNAGEN); PROGENY FAMILY OF CRT-D'S (INCEPTA, ENERGEN, & PUNCTUA) (P010012/S376) | Boston Scientific Corp | 2015-01-29 |
| IN PACT ADMIRAL PACLITAXEL-COATING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLON CATHETER (P140010/S001) | Medtronic, Inc. | 2015-01-29 |
| NG3 FAMILY OF ICD'S (ORIGEN, INOGEN, & DYNAGEN); PROGENY FAMILY OF ICD'S (INCEPTA, ENERGEN, & PUNCTUA) (P960040/S336) | Boston Scientific | 2015-01-29 |
| FORTIFY VR,FORTIFY DR,FORTIFY ASSURA VR, FORTIFY ASSURA DR ICDS (P910023/S351) | ABBOTT MEDICAL | 2015-01-28 |
| UNIFY,UNIFY ASSURA,UNIFY QUADRA,QUADRA ASSURA CRT-DS (P030054/S280) | ABBOTT MEDICAL | 2015-01-28 |
| MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) (P140017) | Medtronic, Inc. | 2015-01-27 |
| EVERA S DR/S VR,XT DR, XT VR ICD; ENTRUST; INTRINSIC 30 & INTRINSIC ICD; MARQUIS DR, VR ICD; MAXIMO DR, II, VR ICD; PROT (P980016/S492) | Medtronic Cardiac Rhythm Disease Management | 2015-01-26 |
| MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION (P890003/S313) | Medtronic, Inc. | 2015-01-26 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENTHYTHM, KAPPA D (KAPPA 700) IPG & KAPA (P980035/S384) | Medtronic, Inc. | 2015-01-26 |
| REVO MRI IPG (P090013/S149) | Medtronic, Inc. | 2015-01-26 |
| BRAVA CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA ICD, INSYNC II PROTECT ICD ,III MARQUIS ICD, INSYNC MAXIMO ICD, (P010031/S455) | Medtronic Cardiac Rhythm Disease Management | 2015-01-26 |
| CONSULTA CRT-P, SYNERA CRT-P (P010015/S244) | Medtronic, Inc. | 2015-01-26 |
| FLEXABILITY ABLATION CATHETER (P110016/S013) | ABBOTT MEDICAL | 2015-01-23 |
| LUTONIX DRUG COATED BALLOON (DCB) (P130024/S001) | Lutonix | 2015-01-22 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S110) | W. L. Gore & Associates, Inc. | 2015-01-22 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S071) | W. L. Gore & Associates, Inc. | 2015-01-22 |
| ENDURANT AND ENDURANT II STENT SYSTEM, ENDURANT II AORTO-UNI-LLIAC(AUI) STENT GRAFT SYSTEM, ENDURANT IIS STENT GRAFT SYS (P100021/S041) | Medtronic Vascular | 2015-01-22 |