| LUMAX ICDS/CRT-DS (P050023/S043) | Biotronik, Inc. | 2011-01-20 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S071) | Boston Scientific Scimed, Inc. | 2011-01-20 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD (P080006/S019) | Medtronic, Inc. | 2011-01-20 |
| CARPENTIER EDWARDS PROCINE BIOPROSTHESIS (P870056/S042) | Edwards Lifesciences, LLC | 2011-01-20 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S068) | Boston Scientific Scimed, Inc. | 2011-01-20 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S065) | Boston Scientific Corp | 2011-01-20 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S008) | Corcym Canada Corp | 2011-01-20 |
| CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS (P010041/S026) | Edwards Lifesciences, LLC | 2011-01-20 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S075) | Edwards Lifesciences, LLC | 2011-01-20 |
| CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS (P870077/S038) | Edwards Lifesciences, LLC | 2011-01-20 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S067) | Boston Scientific Scimed, Inc. | 2011-01-19 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S070) | Boston Scientific Scimed, Inc. | 2011-01-19 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S053) | Medtronic, Ireland | 2011-01-19 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S004) | Medtronic Vascular | 2011-01-19 |
| VIRTUOSO II/SECURA/MAXIMO II ICDS (P980016/S271) | Medtronic Cardiac Rhythm Disease Management | 2011-01-19 |
| CONTAK RENEWAL TR (P030005/S072) | Guidant Corp. | 2011-01-19 |
| CONTAK RENEWAL 3/LIVIAN/COGNIS (P010012/S262) | Boston Scientific Corp | 2011-01-19 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S064) | Boston Scientific Corp | 2011-01-19 |
| PRIZM HE/3/VITALITY/2/AVT/CONFIENT/TELIGEN (P960040/S240) | Boston Scientific | 2011-01-19 |
| CONCERTO II/MAXIMO II/CONSULTA CRT-DS (P010031/S226) | Medtronic Cardiac Rhythm Disease Management | 2011-01-19 |
| VIRTUOSO II/SECURA/MAXIMO II ICDS (P980016/S272) | Medtronic Cardiac Rhythm Disease Management | 2011-01-19 |
| TAXUS EXPRESS EXPRESS ATOM STENT (P030025/S092) | Boston Scientific Corp | 2011-01-19 |
| CONCERTO II/MAXIMO II/CONSULTA CRT-DS (P010031/S227) | Medtronic Cardiac Rhythm Disease Management | 2011-01-19 |
| ON-X ASCENDING AORTIC PROSTHESIS (P000037/S018) | On-X Life Technologies, Inc. | 2011-01-14 |
| TAXUS LIBERTE MONORAIL & OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S063) | Boston Scientific Corp | 2011-01-14 |
| ACCENT PACERS AND ANTHEM RF CRT-P DEVICES (P030035/S076) | ABBOTT MEDICAL | 2011-01-14 |
| ACCENT PACERS AND ANTHEM RF CRT-P DEVICES (P880086/S196) | ABBOTT MEDICAL | 2011-01-14 |
| VERIFLEX (LIBERTE) MONORAIL & OTW CORONARY STENT SYSTEM (P040016/S066) | Boston Scientific Scimed, Inc. | 2011-01-14 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P070015/S045) | Abbott Vascular, Inc. | 2011-01-14 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S003) | Medtronic Vascular | 2011-01-14 |
| VENTAK AV/VENTAK PRIZM DR/VR/VITALITY ICDS (P960040/S239) | Boston Scientific | 2011-01-14 |
| EXPRESS/EXPRESS2 MONORAIL & OTW CORONARY STENT SYSTEM (P020009/S069) | Boston Scientific Scimed, Inc. | 2011-01-14 |
| FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM (P100028) | Cook Medical Incorporated | 2011-01-14 |
| CONTAK CD & EASYTRAK CRT-D SYSTEM (P010012/S261) | Boston Scientific Corp | 2011-01-14 |
| CONCERTO II/CONSULTA /MAXIMO II CRT-DS (P010031/S225) | Medtronic Cardiac Rhythm Disease Management | 2011-01-13 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S068) | Boston Scientific Scimed, Inc. | 2011-01-13 |
| LIBERTE CORONARY STENT SYSTEM (P040016/S065) | Boston Scientific Scimed, Inc. | 2011-01-13 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S062) | Boston Scientific Corp | 2011-01-13 |
| SECURA DRVR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS (P980016/S270) | Medtronic Cardiac Rhythm Disease Management | 2011-01-13 |
| ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD (P080006/S014) | Medtronic, Inc. | 2011-01-13 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S018) | Boston Scientific Corp | 2011-01-13 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S030) | W. L. Gore & Associates, Inc. | 2011-01-13 |
| EXPRESS LD IIIAC PREMOUNTED STENT SYSTEM (P090003/S008) | Boston Scientific Corporation | 2011-01-13 |
| MEDTRONIC ATTAIN STARFIX MODEL 4195 (P060039/S016) | Medtronic, Inc. | 2011-01-13 |
| THERAPY ABLATION CATHETER (P040014/S015) | Irvine Biomedical, Inc. | 2011-01-11 |
| THERAPY COOL PATH ABLATION CATHETER (P060019/S015) | Irvine Biomedical, Inc. | 2011-01-11 |
| THERAPY DUAL 8 ABLATION CATHETER (P040042/S020) | Irvine Biomedical,Inc.(Ibi) | 2011-01-11 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S021) | Zoll Manufacturing Corporation | 2011-01-10 |
| CVS-300 EXCIMER LASER SYSTEM (P910001/S034) | Spectranetics Corp. | 2011-01-10 |
| INSYNC/INSYNC MARQUIS/INSYNC II/III MARQUIS/INSYNC II PROTECT/SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS (P010031/S224) | Medtronic Cardiac Rhythm Disease Management | 2011-01-07 |
| WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S017) | Boston Scientific Corporation | 2011-01-07 |
| SPRINT QUATTRO (P920015/S072) | Medtronic, Inc. | 2011-01-07 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER (P900056/S101) | Boston Scientific Corp | 2011-01-07 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S005) | Boston Scientific Corp | 2011-01-07 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S055) | Boston Scientific Scimed, Inc. | 2011-01-07 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S087) | Boston Scientific Corp | 2011-01-07 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S033) | St Jude Medical | 2011-01-07 |
| GEM II/MARQUIS/MAXIMO/II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO II DR/VR/SECURA DR/VR ICDS (P980016/S269) | Medtronic Cardiac Rhythm Disease Management | 2011-01-07 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S048) | Boston Scientific Corp | 2011-01-07 |
| MERLIN 3650 PROGRAMMER (P030054/S179) | ABBOTT MEDICAL | 2011-01-07 |
| WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S023) | Boston Scientific Scimed, Inc. | 2011-01-07 |
| FLEXTOME CUTTING BALLOON (P950020/S040) | Boston Scientific Corp | 2011-01-07 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S011) | Boston Scientific Corp | 2011-01-07 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S027) | Abbott Vascular Devices | 2011-01-07 |
| KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S199) | Medtronic, Inc. | 2011-01-07 |
| DEMA IPGS (P990001/S081) | Medtronic, Inc. | 2011-01-07 |
| KAPPA 400 DR/SR IPGS (P970012/S080) | Medtronic, Inc. | 2011-01-07 |
| INSYNC CRT-P/INSYNC III CRT-P (P010015/S106) | Medtronic, Inc. | 2011-01-07 |
| WALLSTENT (TIPS/LLIAC/VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S028) | Boston Scientific Corp | 2011-01-07 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S062) | Boston Scientific Scimed, Inc. | 2011-01-07 |
| DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S052) | Medtronic, Ireland | 2011-01-06 |
| AT500 SYSTEM IPG (P980035/S198) | Medtronic, Inc. | 2011-01-06 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S062) | Medtronic, Inc. | 2011-01-06 |
| INSYNC CRT-P (P010015/S105) | Medtronic, Inc. | 2011-01-06 |
| INSYNC MARQUIS ICD (P010031/S223) | Medtronic Cardiac Rhythm Disease Management | 2011-01-06 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S016) | W. L. Gore & Associates, Inc. | 2011-01-05 |
| PERCLOSE AT 6F & PROGLIDE SUTURE-MEDICATED CLOSURE SYSTEM (P960043/S072) | Abbott Vascular, Inc. | 2011-01-05 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S014) | W. L. Gore & Associates, Inc. | 2011-01-05 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S026) | Medtronic Vascular | 2011-01-05 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S025) | Medtronic Vascular | 2011-01-05 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S024) | Medtronic Vascular | 2011-01-04 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S037) | ABBOTT MEDICAL | 2011-01-04 |
| TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S009) | Syncardia Systems, LLC | 2011-01-04 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S055) | Abbott Vascular, Inc. | 2010-12-30 |
| TRANSVENOUS DEFIBRILLATION LEAD (P950022/S072) | ABBOTT MEDICAL | 2010-12-29 |
| POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM (P040002/S030) | Endologix, LLC | 2010-12-29 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S011) | Spectranetics Corp. | 2010-12-29 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S041) | Spectranetics Corp. | 2010-12-29 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S074) | Edwards Lifesciences, LLC | 2010-12-23 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S178) | ABBOTT MEDICAL | 2010-12-23 |
| COROX OTW-L BP LEFT VENTRICULAR PACING LEAD (P070008/S015) | Biotronik, Inc. | 2010-12-23 |
| CADENCE FAMILY OF ICDS (P910023/S255) | ABBOTT MEDICAL | 2010-12-23 |
| SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR (P980016/S267) | Medtronic Cardiac Rhythm Disease Management | 2010-12-23 |
| AMPLATZER DUCT OCCLUDER (P020024/S024) | ABBOTT MEDICAL | 2010-12-23 |
| SAFIRE BLU AND THERAPY COOL PATH BI-DIRECTIONAL ABLATION CATHETERS (P060019/S016) | Irvine Biomedical, Inc. | 2010-12-23 |
| LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS (P070014/S010) | Bard Peripheral Vascular, Inc. | 2010-12-23 |
| CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D (P010031/S221) | Medtronic Cardiac Rhythm Disease Management | 2010-12-23 |
| GORE EXCLUDER AAA ENDOPROSTHESIS WITH MODIFIED DELIVERY SYSTEM (P020004/S052) | W. L. Gore & Associates, Inc. | 2010-12-22 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S037) | Edwards Lifesciences, LLC | 2010-12-22 |
| EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES (P000007/S026) | Edwards Lifesciences, LLC | 2010-12-22 |