| EPIC HF/ATLAS+ HF/ATLAS+ HF/PROMOTE FAMILY OF CRT-DS (P030054/S220) | ABBOTT MEDICAL | 2012-03-21 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND RETROFLEX 3 DELIVERY SYSTEM (P100041/S006) | Edwards Lifesciences, LLC | 2012-03-20 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S011) | Corcym Canada Corp | 2012-03-19 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S045) | W. L. Gore & Associates, Inc. | 2012-03-16 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S070) | W. L. Gore & Associates, Inc. | 2012-03-16 |
| ATTAIN ABILITY, ATTAIN ABILITY PLUS & ATTAIN ABILITY STRAIGHT (P080006/S039) | Medtronic, Inc. | 2012-03-16 |
| PUNCTUA ICD MODELS (E050, E051, E052, E052), ENERGEN ICD MODELS (E140, E141, E142, E143) INCEPTA ICD MODELS (E160, E161, (P960040/S252) | Boston Scientific | 2012-03-15 |
| STRATOS LV/LV-T (P070008/S030) | Biotronik, Inc. | 2012-03-15 |
| VARIOUS FAMILIES OF PHILOS, CYLOS, EVIA, ENTOVIS, ESTELLA, ECURO, & EFFECTA IMPLANTABLE PACEMAKERS (P950037/S104) | Biotronik, Inc. | 2012-03-15 |
| STELID II BTF/BJF STEROID COLLAR (P020030/S007) | MicroPort CRM USA, Inc. | 2012-03-15 |
| BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S048) | Biotronik, Inc. | 2012-03-15 |
| PUNCTUA CRT-D MODELS (N050, N051), ENERGEN CRT-D MODELS (N140, N141) INCEPTA CRT-D MODELS (N160, N161, N164) (P010012/S282) | Boston Scientific Corp | 2012-03-15 |
| KRONOS LV-T CRT-D AND LUMAX 300/340 & 500/540 CRT-D'S & ICD'S (P050023/S052) | Biotronik, Inc. | 2012-03-15 |
| UNIFY FAMILY OF CRT-DS AND LEADS (P030054/S216) | ABBOTT MEDICAL | 2012-03-14 |
| FORTIFY FAMILY OF ICDS (P910023/S289) | ABBOTT MEDICAL | 2012-03-14 |
| XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S082) | Abbott Vascular, Inc. | 2012-03-13 |
| PROMOTE Q/PROMOTE QUADRA/UNIFY QUADRA/QUARTET CRT-DS (P030054/S215) | ABBOTT MEDICAL | 2012-03-12 |
| CADENCE ICD SYSTEM (P910023/S288) | ABBOTT MEDICAL | 2012-03-12 |
| PROTECTA DR/PROTECTA VR/PROTECTA XT DR/PROTECTA XT VR (P980016/S338) | Medtronic Cardiac Rhythm Disease Management | 2012-03-09 |
| ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT (P080006/S038) | Medtronic, Inc. | 2012-03-09 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S154) | Medtronic, Inc. | 2012-03-09 |
| PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S291) | Medtronic Cardiac Rhythm Disease Management | 2012-03-09 |
| EPIC HF/ATLAS + HF FAMILY (P030054/S196) | ABBOTT MEDICAL | 2012-03-09 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL) (P100023/S036) | Boston Scientific Corp | 2012-03-09 |
| CADENCE FAMILY OF ICDS (P910023/S270) | ABBOTT MEDICAL | 2012-03-09 |
| REVO MRI SURESCAN (P090013/S053) | Medtronic, Inc. | 2012-03-09 |
| ADVISA DR (P980035/S260) | Medtronic, Inc. | 2012-03-09 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P110010/S007) | Boston Scientific Corp | 2012-03-09 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S016) | Cryolife, Inc. | 2012-03-07 |
| REVO MRI IPG (P090013/S051) | Medtronic, Inc. | 2012-03-07 |
| ADVISA DR, VERSA, ENRHYTHM, RELIA, & VARIOUS FAMILIES OF ADAPTA & SENSIA IPGS (P980035/S258) | Medtronic, Inc. | 2012-03-07 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S090) | Abbott Vascular, Inc. | 2012-03-07 |
| INSYNC III MARQUIS & INSYNC MAXIMO ICDS (P010031/S288) | Medtronic Cardiac Rhythm Disease Management | 2012-03-07 |
| RX ZETA, OTW ZETA (P970020/S071) | Abbott Vascular, Inc. | 2012-03-07 |
| CARBO-SEAL AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESES (P900060/S048) | Corcym S.r.l. | 2012-03-07 |
| VISION RX, VISION OTW MINI VISION RX, MINI VISION OTW (P020047/S043) | Abbott Vascular | 2012-03-07 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S013) | Abbott Vascular | 2012-03-07 |
| INTRINSIC, MARQUIS DR/VR, & MAXIMO DR/VR ICDS (P980016/S335) | Medtronic Cardiac Rhythm Disease Management | 2012-03-07 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023) | Medtronic Vascular, Inc. | 2012-03-07 |
| ESOPHAGEAL PACING SYSTEM (P860008/S020) | Cardio Command | 2012-03-06 |
| MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM) (P980016/S336) | Medtronic Cardiac Rhythm Disease Management | 2012-03-05 |
| TALENT CAPTIVIA STENT GRAFT SYSTEM (P070007/S034) | Medtronic Vascular | 2012-03-05 |
| STRATOS LV/LV-T (P070008/S029) | Biotronik, Inc. | 2012-03-05 |
| EASYTRAK 3 IS-1 LEADS (P010012/S274) | Boston Scientific Corp | 2012-03-05 |
| LUMAX ICDS AND CRT-DS (P050023/S051) | Biotronik, Inc. | 2012-03-05 |
| ACUITY STEERABLE IS-1 LEADS (P050046/S012) | Guidant Corp. | 2012-03-05 |
| VARIOUS FAMILIES OF PHILOS, CYLOS, EVIA, ENTOVIS, ESTELLA, ECURO, & EFFECTA IMPLANTABLE PACEMAKERS (P950037/S103) | Biotronik, Inc. | 2012-03-05 |
| MEDTRONIC PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 DEVICES (D314TRM, D334TRM, D204TRM AND D264TRM) (P010031/S289) | Medtronic Cardiac Rhythm Disease Management | 2012-03-05 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S035) | Boston Scientific Corp | 2012-03-02 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S012) | Abbott Vascular | 2012-03-02 |
| XIENCE V EVEROLIMUS CORONARY STENT SYSTEM & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S089) | Abbott Vascular, Inc. | 2012-03-02 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S024) | Boston Scientific Corp | 2012-03-02 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S084) | Boston Scientific Scimed, Inc. | 2012-03-02 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY SYSTEM (P060008/S085) | Boston Scientific Corp | 2012-03-02 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM (P020009/S081) | Boston Scientific Scimed, Inc. | 2012-03-02 |
| PROMOTE Q/PROMOTE QUADRA/UNIFY QUADRA/QUARTET CRT-DS (P030054/S214) | ABBOTT MEDICAL | 2012-03-02 |
| COGNIS, CONTAK RENEWAL 3/3 HE, LIVIAN CRT-DS (P010012/S281) | Boston Scientific Corp | 2012-03-01 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S106) | Boston Scientific Corp | 2012-03-01 |
| LEGOO ENDOVASCULAR OCCLUDER (P110003/S001) | Genzyme Corp. | 2012-03-01 |
| TELIGEN, VENTAK PRIZM HE, CONFIENT, & VARIOUS FAMILIES OF VITALITY ICDS (P960040/S251) | Boston Scientific | 2012-03-01 |
| CONSULTA & SYNCRA CRT-PS (P010015/S152) | Medtronic, Inc. | 2012-02-29 |
| INSYNC III MARQUIS & INSYNC MAXIMO ICDS (P010031/S287) | Medtronic Cardiac Rhythm Disease Management | 2012-02-29 |
| MEDTRONIC PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 DEVICES (D314TRM, D334TRM, D204TRM AND D264TRM) (P010031/S290) | Medtronic Cardiac Rhythm Disease Management | 2012-02-29 |
| FLEXTEND LEADS (P960006/S032) | Boston Scientific | 2012-02-29 |
| EASYTRAK 2 LV-1 & IS-1, EASYTRAK 3 LV-1 & IS-1, AND ACUITY SPIRAL LEADS (P010012/S279) | Boston Scientific Corp | 2012-02-29 |
| ENDOTAK RELIANCE S RX IS-1/EZ IS-1/4-SITE EZ/4-SITE RX LEADS (P910073/S100) | Boston Scientific | 2012-02-29 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S013) | Medtronic Vascular | 2012-02-29 |
| ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD (P910077/S118) | Boston Scientific | 2012-02-29 |
| THINLINE II STEROX, FINELINE II STEROX & FINELINE II STEROX EZ LEADS (P960004/S050) | Boston Scientific | 2012-02-29 |
| MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM) (P980016/S337) | Medtronic Cardiac Rhythm Disease Management | 2012-02-29 |
| ACUITY STEERABLE IS-1 LEADS (P050046/S013) | Guidant Corp. | 2012-02-29 |
| VITATRON C20 SR/C60 DR/T20 SR/T60 DR IPGS (P990001/S100) | Medtronic, Inc. | 2012-02-29 |
| REVO MRI (P090013/S050) | Medtronic, Inc. | 2012-02-29 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S112) | Boston Scientific Corp | 2012-02-29 |
| INTRINSIC, MARQUIS DR/VR, & MAXIMO DR/VR ICDS (P980016/S334) | Medtronic Cardiac Rhythm Disease Management | 2012-02-29 |
| ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S079) | ABBOTT MEDICAL | 2012-02-29 |
| ADVISA DR, VERSA, ENRHYTHM, RELIA, & VARIOUS FAMILIES OF ADAPTA & SENSIA IPGS (P980035/S257) | Medtronic, Inc. | 2012-02-29 |
| FEMORAL INTRODUCER SHEATH AND HEMOSTASIS DEVICE (P050043/S006) | Morris Innovative Research, Inc. | 2012-02-28 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S053) | Spectranetics Corp. | 2012-02-24 |
| ICS 3000 IMPLANT MODULE AUTOMATED TEST (P820076/S025) | Biotronik, Inc. | 2012-02-24 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S034) | Spectranetics (Philips) | 2012-02-24 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS, 3000/3000TFX AND 3300TFX (P860057/S085) | Edwards Lifesciences, LLC | 2012-02-24 |
| STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP (P070008/S024) | Biotronik, Inc. | 2012-02-24 |
| EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO (P950037/S097) | Biotronik, Inc. | 2012-02-24 |
| OPTISENSE LEAD MODEL 1999 TUBING (P960013/S070) | ABBOTT MEDICAL | 2012-02-23 |
| VIGILA AND VOLTA AND PASSIVE FIXATION BIPOLAR STEROID ELUTING ICD LEADS (P980023/S046) | Biotronik, Inc. | 2012-02-22 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P100023/S015) | Boston Scientific Corp | 2012-02-22 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P030025/S086) | Boston Scientific Corp | 2012-02-22 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P060008/S046) | Boston Scientific Corp | 2012-02-22 |
| CARDIOGENESIS HOLMIUM TMR SYSTEM (P970029/S014) | Cryolife, Inc. | 2012-02-22 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028) | Abbott Vascular, Inc. | 2012-02-22 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S044) | Abbott Vascular | 2012-02-21 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S010) | Abbott Vascular | 2012-02-21 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S032) | Spectranetics (Philips) | 2012-02-17 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S051) | Spectranetics Corp. | 2012-02-17 |
| RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013) | Medtronic Vascular | 2012-02-17 |
| ON-X PROSTHETIC HEART VALVE (P000037/S024) | On-X Life Technologies, Inc. | 2012-02-17 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S005) | Edwards Lifesciences, LLC | 2012-02-17 |
| REPLY/ESPRIT (P950029/S066) | MicroPort CRM USA, Inc. | 2012-02-16 |
| CONTAK RENEWAL TR (P030005/S081) | Guidant Corp. | 2012-02-16 |