| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S047) | Corcym S.r.l. | 2011-11-29 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P030054/S173) | ABBOTT MEDICAL | 2011-11-29 |
| GORE VIABAHN ENDOPROSTHESIS & GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S039) | W. L. Gore & Associates, Inc. | 2011-11-23 |
| INSYNC III (P010015/S143) | Medtronic, Inc. | 2011-11-23 |
| CONSULTA & SYNCRA CRT-PS (P010015/S144) | Medtronic, Inc. | 2011-11-23 |
| REPLY & ESPRIT SR/DR (P950029/S064) | MicroPort CRM USA, Inc. | 2011-11-23 |
| CADENCE FAMILY OF ICDS (P910023/S277) | ABBOTT MEDICAL | 2011-11-23 |
| 350 SERIES/ENRHYTHM/SIGMA (P980035/S247) | Medtronic, Inc. | 2011-11-23 |
| REVO MRI (P090013/S043) | Medtronic, Inc. | 2011-11-23 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S204) | ABBOTT MEDICAL | 2011-11-23 |
| CADENCE FAMILY OF ICDS (P910023/S278) | ABBOTT MEDICAL | 2011-11-23 |
| VITATRON DA+C & T SERIES (P990001/S098) | Medtronic, Inc. | 2011-11-23 |
| EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S205) | ABBOTT MEDICAL | 2011-11-23 |
| ADVISA (P980035/S248) | Medtronic, Inc. | 2011-11-23 |
| PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM & PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM (P960043/S076) | Abbott Vascular, Inc. | 2011-11-23 |
| MODEL 4195 ATTAIN STARFIX LEAD (P060039/S021) | Medtronic, Inc. | 2011-11-22 |
| MEDTRONIC ADVISA DR A4DR01 IMPLANTABLE PULSE GENERATOR (P980035/S245) | Medtronic, Inc. | 2011-11-22 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010) | Boston Scientific Corp | 2011-11-22 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S025) | Bard Peripheral Vascular, Inc. | 2011-11-21 |
| CAPSURE FIX (P090013/S028) | Medtronic, Inc. | 2011-11-18 |
| ATTAIN (P010015/S129) | Medtronic, Inc. | 2011-11-18 |
| RELIANCE 4-SITE IS-4 LEADS (P910073/S099) | Boston Scientific | 2011-11-18 |
| ATTAIN STARFIX (P060039/S026) | Medtronic, Inc. | 2011-11-18 |
| TRANSVENE CS/SVC (P980050/S062) | Medtronic, Inc. | 2011-11-18 |
| CAPSURE/VITATRON CRYSTALINE/EXCELLENCE PS+ (P830061/S066) | Medtronic Cardiac Rhythm Disease Management | 2011-11-18 |
| SELECTSECURE (P030036/S032) | Medtronic Cardiac Rhythm Disease Management | 2011-11-18 |
| SPRINT QUATTRO/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD (P920015/S078) | Medtronic, Inc. | 2011-11-18 |
| CAPSURE/CAPSURE Z NOVUS/VITATRON EXCELLENCE SS+/VITATRON IMPULSE II (P850089/S078) | Medtronic Cardiac Rhythm Disease Management | 2011-11-18 |
| ATTAIN ABILITY (P080006/S029) | Medtronic, Inc. | 2011-11-18 |
| CAPSURE (P890003/S229) | Medtronic, Inc. | 2011-11-18 |
| SPECTRANETICS LASER SHEATH (SLSII) (P960042/S023) | Spectranetics (Philips) | 2011-11-18 |
| SPECTRANETICS CORONARY ATHERECTOMY (ELCA) CATHETERS (P910001/S040) | Spectranetics Corp. | 2011-11-18 |
| CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX & PIROUET S+ (P930039/S056) | Medtronic, Inc. | 2011-11-18 |
| CONSULTA CRT-D, MAXIMO II CRT-D, & VARIOUS FAMILIES/MODELS OF CONCERTO, INSYNC, & PROTECTA (P010031/S277) | Medtronic Cardiac Rhythm Disease Management | 2011-11-17 |
| JEWEL AF, GEM III AT (P980050/S067) | Medtronic, Inc. | 2011-11-17 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM (P020025/S031) | Boston Scientific | 2011-11-17 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S029) | Bard Peripheral Vascular, Inc. | 2011-11-17 |
| KAPPA 400 IPG (P970012/S089) | Medtronic, Inc. | 2011-11-17 |
| REVO MRI (P090013/S040) | Medtronic, Inc. | 2011-11-17 |
| E-LUMINEXX VASCULAR STENT (P080007/S009) | Bard Peripheral Vascular, Inc. | 2011-11-17 |
| CHILLI II COOLED ABLATION SYSTEM & STERILE CABLES (P980003/S031) | Boston Scientific Corp | 2011-11-17 |
| DIVA IPG FAMILY, DEMA IPG FAMILY, & VARIOUS C-SERIES & T-SERIES DEVICES (P990001/S096) | Medtronic, Inc. | 2011-11-17 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S064) | W. L. Gore & Associates, Inc. | 2011-11-17 |
| BLAZER II, BLAZER II HTD CARDIAC ABLATION CATHETERS & BLAZER PRIME HTD CARDIAC ABLATION CATHETER & STERILE CABLES (P920047/S049) | Boston Scientific Corp | 2011-11-17 |
| CONSULTA CRT-P, SYNCRA CRT-P, INSYNC/INSYNC III (P010015/S139) | Medtronic, Inc. | 2011-11-17 |
| BARD LIFESTENT SOLO VASCULAR STENT SYSTEMS (P070014/S027) | Bard Peripheral Vascular, Inc. | 2011-11-17 |
| ENTRUST, INTRINSIC, MARQUIS, ONYX, SECURA, & VARIOUS FAMILIES/MODELS OF GEM, MAXIMO, PROTECTA, & VIRTUOSO (P980016/S323) | Medtronic Cardiac Rhythm Disease Management | 2011-11-17 |
| VARIOUS FAMILIES/MODELS OF PASYS, SPECTRAX, SYMBIOS, & SYNERGYST (P820003/S113) | Medtronic Cardiac Rhythm Disease Management | 2011-11-17 |
| ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, RELIA, SENSIA, SIGMA, VERSA, & VARIOUS FAMILIES/MODELS OF KAPPA (P980035/S242) | Medtronic, Inc. | 2011-11-17 |
| PRODIGY, MINUET, SYNERGYST II, & VARIOUS FAMILIES/MODELS OF ELITE, PREVA, THERA, & VITATRON LEGACY (P890003/S235) | Medtronic, Inc. | 2011-11-17 |
| INCEPTA, ENERGEN, PUNCTUA AND COGNIS CRT-D (P010012/S255) | Boston Scientific Corp | 2011-11-17 |
| VITATRON LEGACY, PREVAIL, PREMIER, & VARIOUS FAMILIES/MODELS OF ACTIVITRAX, LEGEND, MINIX (P850051/S078) | Medtronic, Inc. | 2011-11-17 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S022) | Bard Peripheral Vascular | 2011-11-17 |
| INCEPTA, ENERGEN, PUNCTUA AND TELIGEN ICDS (P960040/S235) | Boston Scientific | 2011-11-17 |
| LEGEND PLUS (P930022/S013) | Medtronic, Inc. | 2011-11-17 |
| GEM, PCD, & VARIOUS FAMILIES/MODELS OF JEWEL (P900061/S110) | Medtronic Cardiac Rhythm Disease Management | 2011-11-17 |
| LUMAX 500/540 ICDS THORACIC IMPEDANCE (P050023/S047) | Biotronik, Inc. | 2011-11-17 |
| LIFESTAR VASCULAR STENT SYSTEMS (P080007/S007) | Bard Peripheral Vascular, Inc. | 2011-11-16 |
| XIENCE V, PROMUS & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S083) | Abbott Vascular, Inc. | 2011-11-15 |
| ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE (P930038/S069) | Terumo Medical Corporation | 2011-11-15 |
| MEDTRONIC OPEN PIVOT HEART VALVE (P990046/S025) | Medtronic Ats Medical, Inc. | 2011-11-15 |
| RF CONTACTR, RF CONDUCTR, RF MARINR, RF MARINR 5FR AND RF ENHANCER II FAMILIES OF ABLATION CATHETERS (P930029/S034) | Medtronic, Inc. | 2011-11-14 |
| THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9 (P060019/S019) | Irvine Biomedical, Inc. | 2011-11-10 |
| CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S259) | Medtronic Cardiac Rhythm Disease Management | 2011-11-10 |
| CHILLI COOLED ABLATION SYSTEM (P980003/S032) | Boston Scientific Corp | 2011-11-10 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S024) | W. L. Gore & Associates, Inc. | 2011-11-10 |
| MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II (P980016/S305) | Medtronic Cardiac Rhythm Disease Management | 2011-11-10 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S062) | W. L. Gore & Associates, Inc. | 2011-11-10 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S077) | ABBOTT MEDICAL | 2011-11-10 |
| THERAPY CARDIAC ABLATION SYSTEM (P040014/S018) | Irvine Biomedical, Inc. | 2011-11-10 |
| THERAPY DUAL 8 CARDIAC ABLATION SYSTEM (P040042/S023) | Irvine Biomedical,Inc.(Ibi) | 2011-11-10 |
| MEDTRONIC PROTECTA XT CRT-D D314TRM AND PROTECTA CRT-D D334 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P010031/S178) | Medtronic Cardiac Rhythm Disease Management | 2011-11-09 |
| MEDTRONIC PROTECTA XT DR D314DRM, PROTECTA DR D334DRM, CARDIOVERTER DEFIBRILLATORS (P980016/S218) | Medtronic Cardiac Rhythm Disease Management | 2011-11-09 |
| MEDTRONIC CARELINK MONITOR MODEL 2490C, CARDIOSIGHT READER (P890003/S181) | Medtronic, Inc. | 2011-11-09 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S025) | W. L. Gore & Associates, Inc. | 2011-11-04 |
| ENDOLUMINAL PROSTHESIS (P040002/S034) | Endologix, LLC | 2011-11-04 |
| NOVOSTE BETA-CATH SYSTEM (P000018/S045) | Best Vascular, Inc. | 2011-11-04 |
| ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA (P980035/S246) | Medtronic, Inc. | 2011-11-03 |
| REVO MRI (P090013/S041) | Medtronic, Inc. | 2011-11-03 |
| CONCERTO II/CONSULTA/MAXIMO II/PROTECCTA/PROTECTA XT (P010031/S278) | Medtronic Cardiac Rhythm Disease Management | 2011-11-03 |
| CONSULTA CRT-P & SYNCRA CRT-P (P010015/S141) | Medtronic, Inc. | 2011-11-03 |
| MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO II (P980016/S324) | Medtronic Cardiac Rhythm Disease Management | 2011-11-03 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S038) | Boston Scientific Corp | 2011-11-02 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041) | Edwards Lifesciences, LLC | 2011-11-02 |
| ADAPTA/VERSA/SENSIA AND RELIA IMPLANTABLE PULSE GENERATOR (P980035/S244) | Medtronic, Inc. | 2011-11-01 |
| FORTIFY AND VARIOUS FAMILIES OF CURRENT (P030054/S202) | ABBOTT MEDICAL | 2011-11-01 |
| TENDRIL STS 1988TC AND 2088TC (P960013/S066) | ABBOTT MEDICAL | 2011-11-01 |
| VARIOUS FAMILIES OF PROMOTE AND UNIFY (P910023/S276) | ABBOTT MEDICAL | 2011-11-01 |
| Xience Skypoint Everolimus Eluting Coronary Stent System (P110019) | Abbott Vascular | 2011-11-01 |
| VERIFLEX (FORMERLY LIBERTE) CORONARY STENT SYSTEM (P040016/S080) | Boston Scientific Scimed, Inc. | 2011-10-31 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S081) | Boston Scientific Corp | 2011-10-31 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S081) | Boston Scientific Scimed, Inc. | 2011-10-31 |
| BARD E-LUMINEXX VASCULAR STENT (P080007/S008) | Bard Peripheral Vascular, Inc. | 2011-10-31 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S026) | Boston Scientific Corp | 2011-10-31 |
| ENTRUST; INTRINSIC; MARQUIS; ONYX; SECURA; VARIOUS FAMILIES OF GEM, MAXIMO, PROTECTA, & VIRTUOSO (P980016/S321) | Medtronic Cardiac Rhythm Disease Management | 2011-10-31 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S080) | Boston Scientific Corp | 2011-10-31 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S021) | Bard Peripheral Vascular | 2011-10-31 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S079) | Boston Scientific Scimed, Inc. | 2011-10-31 |
| CONSULTA; MAXIMO II; & VARIOUS FAMILIES OF CONCERTO, INSYNC, & PROTECTA (P010031/S275) | Medtronic Cardiac Rhythm Disease Management | 2011-10-31 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S028) | Bard Peripheral Vascular, Inc. | 2011-10-31 |