| ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S033) | Boston Scientific Corp | 2012-08-20 |
| ENTRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO II DF4 ICD, MAXIMO II ICD (P980016/S369) | Medtronic Cardiac Rhythm Disease Management | 2012-08-20 |
| CONCERTO ICD, CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II DF (P010031/S322) | Medtronic Cardiac Rhythm Disease Management | 2012-08-20 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S014) | Abbott Vascular | 2012-08-20 |
| VIATRON C20 SR IPG, VITATRON C60 DR IPG, VIATRON T20 SR IPG, VIATRON T60 DR IPG (P990001/S106) | Medtronic, Inc. | 2012-08-20 |
| REVO MRI IPG, RVDR01 (P090013/S067) | Medtronic, Inc. | 2012-08-20 |
| MULTI-LINK 8 AND MULTI-LINK 8 LL CORONARY STENT SYSTEM (CSS) (P020047/S046) | Abbott Vascular | 2012-08-20 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S281) | Medtronic, Inc. | 2012-08-20 |
| CONSULTA CRT-P, C4TR01, SYNCRA CRT-P, C2TR01 (P010015/S167) | Medtronic, Inc. | 2012-08-20 |
| EN TRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO DR ICD, MAXIMO II DF4 ICD, MAXIMO II (P980016/S370) | Medtronic Cardiac Rhythm Disease Management | 2012-08-17 |
| CONSULTA CRT-P, C4TR01, SYNCRA CRT-P C2TR01 (P010015/S168) | Medtronic, Inc. | 2012-08-17 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S282) | Medtronic, Inc. | 2012-08-17 |
| CONCERTO ICD,CONCERTO II CRT-D, CONSULTA DF4 ICD,CONSULTA, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D, (P010031/S323) | Medtronic Cardiac Rhythm Disease Management | 2012-08-17 |
| VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR IPG (P990001/S107) | Medtronic, Inc. | 2012-08-17 |
| REVO MRI IPG, RVDR01 (P090013/S068) | Medtronic, Inc. | 2012-08-17 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S015) | Medtronic Vascular | 2012-08-16 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P110010/S010) | Boston Scientific Corp | 2012-08-16 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S008) | Medtronic Vascular | 2012-08-16 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVA DELIVERY SYSTEM (P100040/S007) | Medtronic Vascular | 2012-08-16 |
| TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT HYDRO DELIVER SYSTEM (P070027/S034) | Medtronic Vascular | 2012-08-16 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S002) | Medtronic, Ireland | 2012-08-16 |
| RESOLUTE INTEGRITY & MICROTRAC ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S001) | Medtronic Vascular | 2012-08-16 |
| DRIVER AND MICRO-DRIVER AND INTEGRITY CORONARY STENT SYSTEMS (P030009/S061) | Medtronic, Ireland | 2012-08-16 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S070) | Medtronic, Inc. | 2012-08-16 |
| TALENT THORACIC STENT GRAFT SYSTEM WITH THE XCELERANT AND CAPTIVA DELIVERY SYSTEM (P070007/S035) | Medtronic Vascular | 2012-08-16 |
| MEDTRONIC ATTAIN STARFIX MODEL 4195 LEAD (P060039/S033) | Medtronic, Inc. | 2012-08-16 |
| ANEURX AAAADVANTAGE STENT GRAFT WITH XCELERANT HYDRO DELIVERY SYSTEM (P990020/S047) | Medtronic Vascular | 2012-08-16 |
| ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S038) | Boston Scientific Corp | 2012-08-16 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S035) | Zoll Manufacturing Corporation | 2012-08-15 |
| CAPSUREFIX (P930039/S070) | Medtronic, Inc. | 2012-08-15 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S001) | AtriCure, Inc. | 2012-08-15 |
| XIENCE V AND NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S097) | Abbott Vascular, Inc. | 2012-08-14 |
| CAPSUREFIX MRI (P090013/S066) | Medtronic, Inc. | 2012-08-14 |
| MAXIMO II DF4 CRT-D, DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S368) | Medtronic Cardiac Rhythm Disease Management | 2012-08-14 |
| VISION AND MINI-VISION CORONARY STENT SYSTEM (P020047/S049) | Abbott Vascular | 2012-08-14 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CHRONIUM CORONARY STENT SYSTEM (P110010/S025) | Boston Scientific Corp | 2012-08-14 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (CSS) (P970020/S074) | Abbott Vascular, Inc. | 2012-08-14 |
| HERCULINK ELITE RX STENT SYSTEM (P110001/S008) | Abbott Vascular | 2012-08-14 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S050) | Boston Scientific Corp | 2012-08-14 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S005) | Cordis US Corporation | 2012-08-14 |
| XIENCE PRIME AND PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P110019/S026) | Abbott Vascular | 2012-08-14 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D (P010031/S321) | Medtronic Cardiac Rhythm Disease Management | 2012-08-14 |
| MEDTRONIC OPEN PIVOT HEART VALVE (P990046/S026) | Medtronic Ats Medical, Inc. | 2012-08-13 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D (P010031/S320) | Medtronic Cardiac Rhythm Disease Management | 2012-08-10 |
| ADAPTA/VERSA/ENSIA IPG, RELIA IPG (P980035/S278) | Medtronic, Inc. | 2012-08-10 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S015) | Syncardia Systems, LLC | 2012-08-10 |
| MAXIMO II DF4 CRT-D, DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S367) | Medtronic Cardiac Rhythm Disease Management | 2012-08-10 |
| PROMOTE AND UNIFY FAMILIES OF CRT-DS AND LEADS (P030054/S217) | ABBOTT MEDICAL | 2012-08-09 |
| ICD FAMILY OF DEVICES & FORTIFY FAMILY OF DEVICES (P910023/S295) | ABBOTT MEDICAL | 2012-08-09 |
| UNIFY QUADRA CRT-D, UNIFY QUADRA ASSURA (P030054/S223) | ABBOTT MEDICAL | 2012-08-09 |
| EDWARDS SAPIEN THRANSCATHETER HEART VALVE (THV) (P100041/S013) | Edwards Lifesciences, LLC | 2012-08-09 |
| CURRENT AND FORTIFY FAMILIES OF ICDS (P910023/S290) | ABBOTT MEDICAL | 2012-08-09 |
| VARIOUS FAMILIES OF ACTROS, AXIOS, 8A03, CYLOS, DROMOS, KAIROS, PHILOS, PROTOS, EVIA, ENTOVIS, ECURO, EFFECTA, & ESTELLA (P950037/S110) | Biotronik, Inc. | 2012-08-08 |
| BELOS AND LEXOS DR/DR-T/VR-T, LUMOS DR/VR-T, XELOS DR-T ICD'S (P000009/S050) | Biotronik, Inc. | 2012-08-08 |
| KRONOS LV-T & VARIOUS FAMILIES OF LUMAX HF CRT-D's; VARIOUS FAMILIES OF LUMAX DR & VR ICD's (P050023/S054) | Biotronik, Inc. | 2012-08-08 |
| STRATOS LV/LV-T CRT-P (P070008/S033) | Biotronik, Inc. | 2012-08-08 |
| TRIFECTA VALVE (P100029/S014) | ABBOTT MEDICAL | 2012-08-08 |
| MERLIN PATIENT CARE SYSTEM ACCESSORIES (P030054/S225) | ABBOTT MEDICAL | 2012-08-08 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P110019/S023) | Abbott Vascular | 2012-08-06 |
| SELECTSECURE LEAD (P030036/S045) | Medtronic Cardiac Rhythm Disease Management | 2012-08-06 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEADS (P930039/S069) | Medtronic, Inc. | 2012-08-06 |
| ADAPTA,ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, SIGMA DR IPG, SIGMA S IPG (P980035/S279) | Medtronic, Inc. | 2012-08-06 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S013) | Boston Scientific Corporation | 2012-08-03 |
| FINELINE 11 AND THINLINE II (P960004/S053) | Boston Scientific | 2012-08-02 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S046) | Abbott Vascular | 2012-08-02 |
| MAXIMO II DF-4, MAXIMO II, DF-4, PROTECTA DF-4, PROTECTA ICD, PROTECTA XT DF-4, PROTECTA XT ICD, SECURA DF-4, SECURA IC (P010031/S317) | Medtronic Cardiac Rhythm Disease Management | 2012-08-01 |
| CONCERTO ICD, CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA DF-DF-4, PROTECTA XT (P980016/S365) | Medtronic Cardiac Rhythm Disease Management | 2012-08-01 |
| REPLY/ESPIRIT PACEMAKER (P950029/S070) | MicroPort CRM USA, Inc. | 2012-07-31 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S040) | Spectranetics (Philips) | 2012-07-31 |
| PARADYM AND PARADYM RF ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR) (P980049/S076) | MicroPort CRM USA, Inc. | 2012-07-31 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S060) | Spectranetics Corp. | 2012-07-31 |
| OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM (P110043) | Abbott Vascular-Cardiac Therapies | 2012-07-31 |
| CRT-D (CARDIACRESYNCHRONIZATION THERAPY DEFIBRILLATOR) (P060027/S044) | MicroPort CRM USA, Inc. | 2012-07-31 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S069) | Medtronic, Inc. | 2012-07-31 |
| PARADYM RF CRT-D (P060027/S043) | MicroPort CRM USA, Inc. | 2012-07-30 |
| PACEMAKERS, REPLY SR AND DR, ESPIRIT SR AND DR (P950029/S069) | MicroPort CRM USA, Inc. | 2012-07-30 |
| ICD/CRT PARADYM R AND DR, PARADYM CRT-D, PARADYM RF-VR AND DR (P980049/S075) | MicroPort CRM USA, Inc. | 2012-07-30 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S023) | Boston Scientific Corp | 2012-07-27 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S091) | Boston Scientific Corp | 2012-07-26 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S048) | Boston Scientific Corp | 2012-07-26 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S087) | Boston Scientific Scimed, Inc. | 2012-07-26 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S083) | ABBOTT MEDICAL | 2012-07-26 |
| REVO MRI IPG (P090013/S065) | Medtronic, Inc. | 2012-07-26 |
| ADVISA DR IPG, ENRHYTHM IPG (P980035/S276) | Medtronic, Inc. | 2012-07-26 |
| PROMUS ELEMENT PLUS EVEROLIMUS CHROMIUM CORONARY STENT SYSTEM (P110010/S022) | Boston Scientific Corp | 2012-07-26 |
| CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM (P970029/S020) | Cryolife, Inc. | 2012-07-26 |
| ZENITH FENESTRATED AAA ENDOVASULAR GRAFT (P020018/S045) | Cook, Inc. | 2012-07-26 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S165) | Medtronic, Inc. | 2012-07-26 |
| VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM (P040016/S090) | Boston Scientific Scimed, Inc. | 2012-07-26 |
| MECHANICAL HEART VALVES (P810002/S082) | ABBOTT MEDICAL | 2012-07-25 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S058) | Spectranetics Corp. | 2012-07-25 |
| CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S039) | Biosense Webster, Inc. | 2012-07-25 |
| VERIFLEX (LIBERTE) MONORAIL CORONARY STENT SYSTEM (P040016/S092) | Boston Scientific Scimed, Inc. | 2012-07-25 |
| SLS SPECTRECTRANETICS LASER SHEATHS (P960042/S039) | Spectranetics (Philips) | 2012-07-25 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S092) | Boston Scientific Corp | 2012-07-25 |
| ADVISA DR IPG (P980035/S275) | Medtronic, Inc. | 2012-07-25 |
| STOCKERT RADIOFREQUENCY GENERATOR (P990071/S019) | Biosense Webster, Inc. | 2012-07-25 |
| NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S033) | Biosense Webster, Inc. | 2012-07-25 |
| NAVISTAR/CELSIUS DS CATHETERS (P010068/S029) | Biosense Webster, Inc. | 2012-07-25 |
| INCEPTA, TELIGEN, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S259) | Boston Scientific | 2012-07-25 |