| SAPIEN TRANSCATHETER HEART VALVE (THV) (P110021/S045) | Edwards Lifesciences, LLC | 2014-10-20 |
| SAPIEN TRANSCATHETER HEART VALVE (THV) (P100041/S059) | Edwards Lifesciences, LLC | 2014-10-20 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S105) | W. L. Gore & Associates, Inc. | 2014-10-17 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM (P020025/S059) | Boston Scientific | 2014-10-17 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD (P980016/S506) | Medtronic Cardiac Rhythm Disease Management | 2014-10-17 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S092) | Medtronic, Inc. | 2014-10-17 |
| BLAZER II TEMPERATURE ABLATION CATHETERS AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS USED WITH MAESTRO 3000 CARI (P920047/S071) | Boston Scientific Corp | 2014-10-17 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S050) | Boston Scientific Corp | 2014-10-17 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S068) | W. L. Gore & Associates, Inc. | 2014-10-17 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S071) | W. L. Gore & Associates, Inc. | 2014-10-17 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S011) | W. L. Gore & Associates, Inc. | 2014-10-17 |
| 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, EVERA S DR ICD (P010031/S470) | Medtronic Cardiac Rhythm Disease Management | 2014-10-17 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S253) | Medtronic, Inc. | 2014-10-16 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S049) | Medtronic | 2014-10-16 |
| GORE AAA ENDOPROSTHESIS (P020004/S104) | W. L. Gore & Associates, Inc. | 2014-10-16 |
| CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P (P010015/S251) | Medtronic, Inc. | 2014-10-16 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S507) | Medtronic Cardiac Rhythm Disease Management | 2014-10-16 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA I (P980016/S505) | Medtronic Cardiac Rhythm Disease Management | 2014-10-16 |
| PRODIGY IPG (P890003/S323) | Medtronic, Inc. | 2014-10-16 |
| REVO MRI IPG (P090013/S161) | Medtronic, Inc. | 2014-10-16 |
| ORIGEN EL,ORIGEN MINI, INOGEN EL,INOGEN MINI, DYNAGEN EL,DYNAGEN MINI, INCEPTA, ENERGEN, PUNCTUA ICDS (P960040/S333) | Boston Scientific | 2014-10-16 |
| ADAPTA, VERA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S395) | Medtronic, Inc. | 2014-10-16 |
| DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4 ORIGEN,ORIGEN X4, INCEPTA, ENERGEN, PUNCTUA CRT-DS (P010012/S372) | Boston Scientific Corp | 2014-10-16 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D, (P010031/S469) | Medtronic Cardiac Rhythm Disease Management | 2014-10-16 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S126) | Boston Scientific Scimed, Inc. | 2014-10-16 |
| 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/S471) | Medtronic Cardiac Rhythm Disease Management | 2014-10-16 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S132) | Boston Scientific Scimed, Inc. | 2014-10-16 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S396) | Medtronic, Inc. | 2014-10-16 |
| REVO MRI IPG (P090013/S158) | Medtronic, Inc. | 2014-10-16 |
| THERMO-COOL SF (BI-DIRECTIONAL AND UNI-DIRECTIONAL ) CATHETERS (P030031/S061) | Biosense Webster, Inc. | 2014-10-15 |
| FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICES, FREEZOR MAX SURGICAL CRYOABLATION DEVICES, (P020045/S063) | Medtronic Cryocath, LP | 2014-10-15 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETERS, ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS, FREEZOR MAX CARDIAC (P100010/S045) | Medtronic Cryocath, LP | 2014-10-15 |
| SUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S119) | Medtronic, Inc. | 2014-10-14 |
| SPRINT QUATTRO LEAD (P920015/S143) | Medtronic, Inc. | 2014-10-14 |
| CAPSUREFIX MRI LEAD. (P090013/S157) | Medtronic, Inc. | 2014-10-14 |
| MEDTRONIC CAPSUREFIX NOVUS MRI SURESCAN MODEL 5076 LEAD (P930039/S107) | Medtronic, Inc. | 2014-10-13 |
| LINOX SMART SD, LINOX SMART TD, LINOX SMART S, LINOX SMART T, LINOX SMART S DX, VIGILA 1CR, VOLTA 1CR, KAINOX VCS,PROTEG (P980023/S061) | Biotronik, Inc. | 2014-10-10 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S050) | Medtronic | 2014-10-10 |
| EXPRESS2 CORONARY STENT SYSTEM (MONORAIL AND OVER THE WIRE) (P020009/S123) | Boston Scientific Scimed, Inc. | 2014-10-10 |
| MEDTRONIC COREVALVE (R) SYSTEM (P130021/S007) | Medtronic, Inc. | 2014-10-10 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S129) | Boston Scientific Scimed, Inc. | 2014-10-10 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S060) | Boston Scientific Corp | 2014-10-10 |
| ALLURE FAMILY OF CRT-P'S (P030035/S125) | ABBOTT MEDICAL | 2014-10-10 |
| COROX OTW, COROX OTW-L, CELERITY (P070008/S055) | Biotronik, Inc. | 2014-10-10 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S035) | Boston Scientific Corporation | 2014-10-10 |
| PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLINUS-ELTING PLATINUM CHROMINUM CORONARY STENT SYSTEM (P110010/S085) | Boston Scientific Corp | 2014-10-10 |
| ASSURITY/ENDURITY FAMILIES OF PACEMAKERS (P880086/S247) | ABBOTT MEDICAL | 2014-10-10 |
| SELOX ST, SELOX JT, SETROX S, DEXTRUS, TILDA, SOLOX SLX, SAFIO (P950037/S140) | Biotronik, Inc. | 2014-10-10 |
| EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S032) | Boston Scientific Corporation | 2014-10-10 |
| ELLIPSE FAMILY OF ICDS (P910023/S344) | ABBOTT MEDICAL | 2014-10-10 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S007) | Medtronic Vascular, Inc. | 2014-10-10 |
| ON-X PROSTHETIC HEART VALVE (P000037/S038) | On-X Life Technologies, Inc. | 2014-10-10 |
| ILESTO/IFORIA 5 & 7 ICD/CRT-D FAMILIES (P050023/S078) | Biotronik, Inc. | 2014-10-10 |
| ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S098) | Boston Scientific Corp | 2014-10-10 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086) | Cordis Corp. | 2014-10-10 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S032) | Abbott Vascular Devices | 2014-10-10 |
| ML8 CORONARY STENT SYSTEMS (P020047/S059) | Abbott Vascular | 2014-10-09 |
| EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER (P910001/S072) | Spectranetics Corp. | 2014-10-09 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S124) | Abbott Vascular, Inc. | 2014-10-09 |
| LUTONIX DRUG COATED BALLOON PTA CATETER (P130024) | Lutonix | 2014-10-09 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S008) | Abbott Vascular-Cardiac Therapies | 2014-10-09 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) AND XIENCE XPEDITION EVEROLIMUS ELUTI (P110019/S071) | Abbott Vascular | 2014-10-09 |
| SPECTRANETICS LASER SHEATH (SLS, SLS II, AND GLIDELIGHT) (P960042/S049) | Spectranetics (Philips) | 2014-10-09 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S045) | Medtronic Vascular | 2014-10-08 |
| FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM (P100028/S004) | Cook Medical Incorporated | 2014-10-08 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S002) | Cardiva Medical, Inc. | 2014-10-07 |
| ST.JUDE MEDICAL MECHANICAL HEART VALVE, SJM MASTER SERIES MECHANICAL HEART VALVESJM REGENT MECHANICAL HEART VALVE, (P810002/S090) | ABBOTT MEDICAL | 2014-10-07 |
| TUNNELIING TOOL (P920015/S142) | Medtronic, Inc. | 2014-10-07 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S122) | Abbott Vascular, Inc. | 2014-10-03 |
| ENDURANT AND ENDURANT II STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-ILAIAC (AUI) STENT GRAFT SYSTEM (P100021/S040) | Medtronic Vascular | 2014-10-03 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S504) | Medtronic Cardiac Rhythm Disease Management | 2014-10-03 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S012) | Abbott Vascular, Inc. | 2014-10-03 |
| 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/S468) | Medtronic Cardiac Rhythm Disease Management | 2014-10-03 |
| XIENCE PRIME EVERLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE X PEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S066) | Abbott Vascular | 2014-10-03 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S018) | LeMaitre Vascular, Inc. | 2014-10-02 |
| CARPENTIER-EDWARDS PERIMOUNT MITRA & AORTIC,THEON,RSR,THEON RSR,MAGNA,MAGNA EASE WITH& WITHOUT THERMAFEX TISSUE PROCESS (P860057/S128) | Edwards Lifesciences, LLC | 2014-10-02 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S058) | Edwards Lifesciences, LLC | 2014-10-02 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S044) | Edwards Lifesciences, LLC | 2014-10-02 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S503) | Medtronic Cardiac Rhythm Disease Management | 2014-10-02 |
| VAISALA CONTINUOUS MONITORING SYSTEM (P920015/S141) | Medtronic, Inc. | 2014-10-02 |
| ATTAIN PERFORMA MODEL 4298 LEAD (P080006/S074) | Medtronic, Inc. | 2014-10-02 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S011) | Edwards Lifesciences, LLC | 2014-10-02 |
| CONCERTO II CRT-D, CONCULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S467) | Medtronic Cardiac Rhythm Disease Management | 2014-10-02 |
| FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC C (P020045/S062) | Medtronic Cryocath, LP | 2014-10-01 |
| CRYOCONSOLE (P020045/S059) | Medtronic Cryocath, LP | 2014-10-01 |
| FREEZOR MAX CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ADVANCED CRYOBALLOON CATHETER (P100010/S044) | Medtronic Cryocath, LP | 2014-10-01 |
| EDWARDS NOVAFLEX+ DELIVERY SYSTEM (P130009/S009) | Edwards Lifesciences, LLC | 2014-09-30 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM (P110043/S009) | Abbott Vascular-Cardiac Therapies | 2014-09-30 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S006) | Bolton Medical, Inc. | 2014-09-30 |
| VITATRON BRILLIANT S+ VDD LEAD (P890003/S318) | Medtronic, Inc. | 2014-09-30 |
| OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S010) | Endologix, LLC | 2014-09-30 |
| TRIFECTA VALVE (P100029/S017) | ABBOTT MEDICAL | 2014-09-30 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S105) | Boston Scientific Corp | 2014-09-29 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S029) | Syncardia Systems, LLC | 2014-09-29 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S010) | Edwards Lifesciences, LLC | 2014-09-29 |
| PROCOL VASCULAR BIOPROSTHESIS (P020049/S003) | LeMaitre Vascular, Inc. | 2014-09-29 |
| XIENCE XPEDITION/ XIENCE XPEDITION SV/ XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S069) | Abbott Vascular | 2014-09-26 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S003) | Cardiovascular Systems, Inc. | 2014-09-26 |
| ARCTIC FRONT, ARCTIC FRONT ADVANCED, AND FREEZOR MAX CARDIAC CRYOABLATION CATHETERS (P100010/S043) | Medtronic Cryocath, LP | 2014-09-25 |
| FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICES, FREEZOR MAX SURGICAL CRYOABLATION DEVICES (P020045/S061) | Medtronic Cryocath, LP | 2014-09-25 |