| AMPLATZER SEPTAL OCCLUDER AND MULTI-FENESTRATED SEPTAL OCCLUDER (P000039/S045) | ABBOTT MEDICAL | 2012-05-24 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S036) | Spectranetics (Philips) | 2012-05-24 |
| DURATA LEADS (P950022/S078) | ABBOTT MEDICAL | 2012-05-24 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S020) | ABBOTT MEDICAL | 2012-05-24 |
| AMPLATZER DUCT OCCLUDER (P020024/S035) | ABBOTT MEDICAL | 2012-05-24 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S003) | Medtronic Vascular | 2012-05-24 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S088) | Boston Scientific Corp | 2012-05-23 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S097) | Boston Scientific Corp | 2012-05-23 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S042) | Boston Scientific Corp | 2012-05-23 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S084) | Boston Scientific Scimed, Inc. | 2012-05-23 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S087) | Boston Scientific Scimed, Inc. | 2012-05-23 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S036) | Boston Scientific Corp | 2012-05-23 |
| MAXIMO II DF4 & ICD, PROTECTA DF4 & ICD & XT DF4 & XT ICD, SECURA DF4 & ICD, VIRTUOSO II DR/VR ICD (P980016/S351) | Medtronic Cardiac Rhythm Disease Management | 2012-05-23 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S052) | Boston Scientific Corp | 2012-05-23 |
| CONCERTO II CRT-D, CONSULTA & DF4, MAXIMO II CRT-D & DF4, PROTECTA CRT-D & DF4 & XT CRT-D & XT DF4 (P010031/S303) | Medtronic Cardiac Rhythm Disease Management | 2012-05-23 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S034) | Boston Scientific | 2012-05-23 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDWIRE WITH WIRECLIP TORQUER (P900056/S114) | Boston Scientific Corp | 2012-05-23 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S027) | Boston Scientific Corp | 2012-05-23 |
| SMART NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM (P020036/S024) | Cordis US Corporation | 2012-05-22 |
| PRECISE NITINOL STENT SYSTEM (P030047/S025) | Cordis US Corporation | 2012-05-22 |
| SMART NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM (P020036/S025) | Cordis US Corporation | 2012-05-22 |
| INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S258) | Boston Scientific | 2012-05-18 |
| INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S288) | Boston Scientific Corp | 2012-05-18 |
| CONTAK RENEWAL TR CRT-P DEVICES (P030005/S083) | Guidant Corp. | 2012-05-18 |
| HEARTMATE II VENTRICULAR ASSISTE SYSTEM (P060040/S017) | ABBOTT MEDICAL | 2012-05-17 |
| DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM (P950037/S108) | Biotronik, Inc. | 2012-05-17 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S011) | Syncardia Systems, LLC | 2012-05-16 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S037) | Spectranetics (Philips) | 2012-05-16 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2900, 3000TFX, 3300TFX (P860057/S088) | Edwards Lifesciences, LLC | 2012-05-15 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S009) | LeMaitre Vascular, Inc. | 2012-05-11 |
| PROMUS ELEMENT PLUS EVEROLIMUS PLATINUM CHRONIUM CORONARY STENT SYSTEM (P110010/S004) | Boston Scientific Corp | 2012-05-11 |
| SJM CRTDS (P030054/S212) | ABBOTT MEDICAL | 2012-05-10 |
| TALENT CONVERTER STENT GRAFT SYSTEM AND TALENT OCCLUDER SYSTEM (P070027/S032) | Medtronic Vascular | 2012-05-10 |
| CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II M4, PROTECTA CRT-D, PROTECTA M4, PROTECTA XT CRT-D, PROTECTA XT M4 (P980016/S349) | Medtronic Cardiac Rhythm Disease Management | 2012-05-10 |
| SJM ICDS (P910023/S285) | ABBOTT MEDICAL | 2012-05-10 |
| CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II M4, PROTECTA CRT-D, PROTECTA M4, PROTECTA XT CRT-D, PROTECTA XT M4 (P010031/S301) | Medtronic Cardiac Rhythm Disease Management | 2012-05-10 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P110010/S006) | Boston Scientific Corp | 2012-05-10 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S083) | Boston Scientific Corp | 2012-05-09 |
| VERIFLEX (FORMERLY LIBERTE) CORONARY STENT SYSTEM (P040016/S083) | Boston Scientific Scimed, Inc. | 2012-05-09 |
| EXPRESS LD IIIAC PREMOUNTED STENT SYSTEM (P090003/S012) | Boston Scientific Corporation | 2012-05-09 |
| EXPRESS AND EXPRESS2 CORONARY STENT SYSTEMS (P020009/S083) | Boston Scientific Scimed, Inc. | 2012-05-09 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV) (P100041/S009) | Edwards Lifesciences, LLC | 2012-05-09 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEMS (P040016/S086) | Boston Scientific Scimed, Inc. | 2012-05-09 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S048) | Boston Scientific Corp | 2012-05-09 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S026) | Boston Scientific Corp | 2012-05-09 |
| REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS (P950037/S084) | Biotronik, Inc. | 2012-05-08 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S044) | ABBOTT MEDICAL | 2012-05-07 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S211) | ABBOTT MEDICAL | 2012-05-07 |
| CADENCE/ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S279) | ABBOTT MEDICAL | 2012-05-07 |
| EPIC HF/ATLAS+HF/QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S206) | ABBOTT MEDICAL | 2012-05-07 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S075) | St. Jude Medical, Inc. | 2012-05-07 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S089) | ABBOTT MEDICAL | 2012-05-07 |
| XIENCE PRIME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S001) | Abbott Vascular | 2012-05-07 |
| BELOS DR/DR-T/VR/VR-T/LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T/XELOS DR-T (P000009/S047) | Biotronik, Inc. | 2012-05-04 |
| LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T (P050023/S048) | Biotronik, Inc. | 2012-05-04 |
| CYLOS/DR/DR-T/VR/DROMOS DR/SR/SL/KAIROS DR/SR/SL/D/S/PHILOS/DR/DR-T/SR/SLR/D/S/PHILOS II D/DR/S/SLR/SR/DR-T/PROTOS DR/CL (P950037/S100) | Biotronik, Inc. | 2012-05-04 |
| STRATOS LV/LV-T (P070008/S028) | Biotronik, Inc. | 2012-05-04 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S062) | Boston Scientific Corp | 2012-05-04 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S041) | Boston Scientific Corp | 2012-05-04 |
| MAXIMO II ICD, MAXIMO II M4, PROTECTA ICD, PROTECTA M4, XT ICD, PROTECTA XT M4, SECURA ICD, SECURA M4, VIRTUOSO II DR/VR (P010031/S300) | Medtronic Cardiac Rhythm Disease Management | 2012-05-04 |
| CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D, MXIMO II M4, PROTECTA CRT-D, PROTECTA M4, XT CRT-D & XT M4 (P980016/S348) | Medtronic Cardiac Rhythm Disease Management | 2012-05-04 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S096) | Boston Scientific Corp | 2012-05-04 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S087) | Boston Scientific Corp | 2012-05-04 |
| CRT-D FAMILY OF DEVICES & UNIFY QUADRA FAMILY OF DEVICES (P030054/S221) | ABBOTT MEDICAL | 2012-05-03 |
| PUNTUA ICD, TELIGEN, ENERGEN ICD & INCEPTA ICD (P960040/S257) | Boston Scientific | 2012-05-03 |
| PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S079) | Abbott Vascular, Inc. | 2012-05-03 |
| PUNTUA CRT-D , COGNIS, ENERGEN & INCEPTA CRT-D (P010012/S287) | Boston Scientific Corp | 2012-05-03 |
| MICRONY FAMILY OF DEVICES (P970013/S048) | ABBOTT MEDICAL | 2012-05-03 |
| ON-X PROSTHETIC HEART VALVE (P000037/S026) | On-X Life Technologies, Inc. | 2012-05-03 |
| REGENCY FAMILY OF DEVICES (P880006/S079) | St. Jude Medical, Inc. | 2012-05-03 |
| ISOFLEX (ISOFLEX S, ISOFLEX P, ISOFLEX OPTIM) AND PASSIVE PLUS FAMILY OF LEADS (P960030/S036) | ABBOTT MEDICAL | 2012-05-03 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S016) | Medtronic Vascular | 2012-05-03 |
| TENDRIL (TENDRIL, TENDRIL ST, TENDRIL STS) AND OPTISENSE FAMILY OF LEADS (P960013/S072) | ABBOTT MEDICAL | 2012-05-03 |
| PACEMAKER FAMILY OF DEVICES (INTEGRITY, IDENTITY, VERITY, SUSTAIN, VICTORY, ZEPHYR, ACCENT FAMILY OF DEVICES) (P880086/S218) | ABBOTT MEDICAL | 2012-05-03 |
| ICD FAMILY OF DEVICES & FORTIFY FAMILY OF DEVICES (P910023/S294) | ABBOTT MEDICAL | 2012-05-03 |
| CRT-P FAMILY OF DEVICES (FRONTIER, FRONTIER II, ANTHEM FAMILY OF DEVICES) (P030035/S096) | ABBOTT MEDICAL | 2012-05-03 |
| MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER (P890003/S214) | Medtronic, Inc. | 2012-05-02 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S035) | Spectranetics (Philips) | 2012-05-02 |
| PROTECTS XT VR, PROTECTA VR, SECURA VR MAXIMO II ICD (P980016/S280) | Medtronic Cardiac Rhythm Disease Management | 2012-05-02 |
| CONSULTA CRT-P & SYNCRA CRT-P (P010015/S159) | Medtronic, Inc. | 2012-05-02 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S054) | Spectranetics Corp. | 2012-05-02 |
| INVIVE V172, V173 (P030005/S079) | Guidant Corp. | 2012-05-01 |
| FORMULA BALLOOL-EXPANDABLE RENAL STENT SYSTEM (P100028/S002) | Cook Medical Incorporated | 2012-04-30 |
| BARD E-LUMINEXX VASCULAR STENT (P080007/S013) | Bard Peripheral Vascular, Inc. | 2012-04-27 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S071) | W. L. Gore & Associates, Inc. | 2012-04-27 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S031) | Bard Peripheral Vascular, Inc. | 2012-04-27 |
| PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM (P960043/S078) | Abbott Vascular, Inc. | 2012-04-27 |
| ENDURANT II STENT GRAFT SYSTEM (P100021/S011) | Medtronic Vascular | 2012-04-27 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S025) | Bard Peripheral Vascular | 2012-04-27 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S017) | Abbott Vascular | 2012-04-27 |
| TRIFECTA VALVE (P100029/S012) | ABBOTT MEDICAL | 2012-04-26 |
| CONCERTO, CONCERTO II, INSYNC ICD, INSYNC II MARQUIS, INSYNC SENTRY, MAXIMO II, PROTECTA (P010031/S299) | Medtronic Cardiac Rhythm Disease Management | 2012-04-25 |
| ELITE, ELITE II, MINUET, PREVA, PRODIGY, SYNERGYST II, THERA, VITATRON & REVEAL (P890003/S249) | Medtronic, Inc. | 2012-04-25 |
| REVO MRI (P090013/S061) | Medtronic, Inc. | 2012-04-25 |
| ENRHYTHM IPG (P090013/S060) | Medtronic, Inc. | 2012-04-25 |
| REVO MRI IPG (P980035/S267) | Medtronic, Inc. | 2012-04-25 |
| LEGEND PLUS (P930022/S014) | Medtronic, Inc. | 2012-04-25 |
| VITATRON IPGS (P990001/S104) | Medtronic, Inc. | 2012-04-25 |
| CONSULTA, INSYNC, INSYNC III, SYNCRA (P010015/S160) | Medtronic, Inc. | 2012-04-25 |
| ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPPA 900, RELIA (P980035/S268) | Medtronic, Inc. | 2012-04-25 |