| 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 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S043) | Boston Scientific Corp | 2012-05-09 |
| VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S065) | Vistakon, Johnson & Johnson Vision Products, Inc. | 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 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S083) | Boston Scientific Corp | 2012-05-07 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S031) | Boston Scientific Corp | 2012-05-07 |
| ACTICON NEOSPHINTER (P010020/S017) | Boston Scientific Corp | 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 |
| INTEGRA ARTIFICIAL SKIN, DERMAL REGENERATION TEMPLATE (P900033/S020) | Integra Lifesciences Corp. | 2012-05-04 |
| OCUCOAT (2% HYDROXPROPYLMETHYLCELLULOSE SOLUTION) (P860047/S024) | Bausch & Lomb, 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 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S002) | Infusyn Therapeutics, LLC | 2012-05-04 |
| STRATOS LV/LV-T (P070008/S028) | Biotronik, Inc. | 2012-05-04 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S003) | Infusyn Therapeutics, LLC | 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 |
| EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S015) | Ferring Pharmaceuticals, Inc. | 2012-05-04 |
| SUPARTZ (P980044/S013) | Seikagaku Corp. | 2012-05-04 |
| GEL-ONE (P080020/S001) | Seikagaku Corp. | 2012-05-04 |
| SOLESTA (P100014/S006) | Palette Life Sciences | 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 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S043) | Hologic, 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 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S001) | Infusyn Therapeutics, LLC | 2012-05-03 |
| PREVELLE SILK (P030032/S014) | Genzyme Biosurgery | 2012-05-03 |
| LIPOSORBER LA-15 SYSTEM (P910018/S015) | Kaneka Pharma America Corp. | 2012-05-03 |
| SYNVISC & SYNVISC-ONE (P940015/S025) | Sanofi Genzyme Corp. | 2012-05-03 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S090) | Boston Scientific Corp | 2012-05-02 |
| MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER (P890003/S214) | Medtronic, Inc. | 2012-05-02 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S035) | Spectranetics (Philips) | 2012-05-02 |
| ASCENDA INTRATHECAL CATHETER MODELS 8780, 8781, 8782, 8784, 8785, 8786, AND 8787 (P860004/S125) | Medtronic, Inc. | 2012-05-02 |
| MODEL 3587A RESUME II AND 3986A RESUME TL LEADS (P840001/S209) | Medtronic Neuromodulation | 2012-05-02 |
| PROTECTS XT VR, PROTECTA VR, SECURA VR MAXIMO II ICD (P980016/S280) | Medtronic Cardiac Rhythm Disease Management | 2012-05-02 |
| AMS 800 URINARY CONTROL SYSTEM (P000053/S042) | Boston Scientific Corp | 2012-05-02 |
| ACTIVA SC MODEL 37603 IMPLANTABLE NEUROSTIMULATOR (INS) CONNECTOR REWORK (P960009/S141) | Medtronic, Inc. | 2012-05-02 |
| CONSULTA CRT-P & SYNCRA CRT-P (P010015/S159) | Medtronic, Inc. | 2012-05-02 |
| ACTICON NEOSPHINCTER (P010020/S023) | Boston Scientific Corp | 2012-05-02 |
| KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM (P050027/S002) | KARL STORZ Endoscopy-America, Inc. | 2012-05-02 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S054) | Spectranetics Corp. | 2012-05-02 |
| BELOTERO BALANCE (P090016/S001) | Merz North America, Inc. | 2012-05-01 |
| INVIVE V172, V173 (P030005/S079) | Guidant Corp. | 2012-05-01 |
| EXABLATE DEVICE (P040003/S011) | Insightec, Ltd. | 2012-05-01 |
| FORMULA BALLOOL-EXPANDABLE RENAL STENT SYSTEM (P100028/S002) | Cook Medical Incorporated | 2012-04-30 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S057) | Med-El Corp. | 2012-04-30 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S039) | Intera Oncology | 2012-04-30 |
| MINILINK TRANSMITTER/CGMS IPRO RECORDING DEVICE/BATTERY CHARGER (P980022/S102) | Medtronic Minimed | 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 |
| AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S091) | Advanced Bionics | 2012-04-27 |
| PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM (P960043/S078) | Abbott Vascular, Inc. | 2012-04-27 |
| SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK (P990034/S025) | Medtronic, Inc. | 2012-04-27 |
| ENDURANT II STENT GRAFT SYSTEM (P100021/S011) | Medtronic Vascular | 2012-04-27 |
| AUOTDELFIA HAFP KIT (P970037/S007) | Revvity, Inc. | 2012-04-27 |
| PARADIGM REAL-TIME REVEL INSULIN PUMP (P980022/S112) | Medtronic Minimed | 2012-04-27 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S025) | Bard Peripheral Vascular | 2012-04-27 |
| MODEL 855 REFILL KIT (P860004/S163) | Medtronic, Inc. | 2012-04-27 |
| EXATECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S007) | Exactech, Inc. | 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 |
| DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S020) | DePuy Orthopaedics, Inc. | 2012-04-26 |
| SURGICAL SNOW ABSORBABLE HEMOSTAT (N12159/S030) | ETHICON, Inc. | 2012-04-26 |
| ACTICON NEOSPHINCTER (P010020/S022) | Boston Scientific Corp | 2012-04-26 |
| DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S005) | DePuy Orthopaedics, Inc. | 2012-04-26 |
| MINILINK TRANSMITTER (MMT-7703) AND CGMS IPRO RECORDER (MMT-7709) (P980022/S115) | Medtronic Minimed | 2012-04-26 |
| TRIFECTA VALVE (P100029/S012) | ABBOTT MEDICAL | 2012-04-26 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S009) | Exactech, Inc. | 2012-04-26 |
| PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S003) | DePuy Orthopaedics, Inc. | 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 |