| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P110019/S035) | Abbott Vascular | 2012-11-02 |
| ACTIVA SC, 37602 AND 37603 (P960009/S159) | Medtronic, Inc. | 2012-11-02 |
| VISION AND ML8 CORONARY STENT SYSTEMS (P020047/S052) | Abbott Vascular | 2012-11-02 |
| SYNCHROMED II, 8637 (P860004/S176) | Medtronic, Inc. | 2012-11-02 |
| ULTRA AND ZETA RX CORONARY STENT SYSTEMS (P970020/S076) | Abbott Vascular, Inc. | 2012-11-02 |
| C-KIT PHARMDX (P040011/S002) | Dako North America, Inc. | 2012-11-02 |
| ELECSYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG AND ELECSYS HBSAG CONFIRMATORY TEST SYSTEM (P990012/S017) | Roche Diagnostics Corp. | 2012-11-02 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S102) | Abbott Vascular, Inc. | 2012-11-02 |
| INTERSTIM II 3058 (P080025/S040) | Medtronic Neuromodulation | 2012-11-02 |
| LIFEVEST WAERABLE DEFIBRILLATOR (P010030/S031) | Zoll Manufacturing Corporation | 2012-11-02 |
| INTREL 4, 37703 AND 37704 (P840001/S229) | Medtronic Neuromodulation | 2012-11-02 |
| TRIDENT CERAMIC-ON-CERAMIC ACETABULAR SYSTEM (P000013/S011) | Howmedica Osteonics Corp. | 2012-11-02 |
| INTERSTIM THERAPY (P970004/S141) | Medtronic Neuromodulation | 2012-11-01 |
| ABBOTT REALTIME HCV (P100017/S003) | Abbott Molecular, Inc. | 2012-11-01 |
| GEL-ONE (P080020/S003) | Seikagaku Corp. | 2012-11-01 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S078) | ABBOTT MEDICAL | 2012-11-01 |
| MED-EL CONCERT IMPLANT (P000025/S064) | Med-El Corp. | 2012-11-01 |
| ABBOTT REALTIME HBV (P080026/S004) | Abbott Molecular, Inc. | 2012-11-01 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S013) | Exactech, Inc. | 2012-11-01 |
| EPIC VALVE (P040021/S020) | ABBOTT MEDICAL | 2012-11-01 |
| BIOFINITY (CONFILCON A) SOFT CONTACT LENSES (P080011/S018) | CooperVision, Inc. | 2012-11-01 |
| TRIFECA HEART VALVE (P100029/S008) | ABBOTT MEDICAL | 2012-11-01 |
| WALLSTENT ENDO (TIPS) STENT SYSTEM (P930031/S037) | Boston Scientific Corp | 2012-10-31 |
| SPECTRANETICS LASER SHEATH (SLS) II AND GLIDELIGHT LASER SHEATH (P960042/S042) | Spectranetics (Philips) | 2012-10-31 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S094) | Boston Scientific Scimed, Inc. | 2012-10-31 |
| TAXUS LIBERTE CORONARY STENT SYSTEM (P060008/S098) | Boston Scientific Corp | 2012-10-31 |
| PMMA SINGLE-PEICE POSTERIOR CHAMBER INTRAOCULAR LENSES (P840060/S038) | Alcon Laboratories | 2012-10-31 |
| ACYSOF MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENSES (P040020/S043) | Alcon Research, Ltd. | 2012-10-31 |
| ATLAS+HF, ATLAS II, HF, ATLAS II+ HF, EPIC + EPIC HF, EPIC + EPIC II HF, EPIC II + HF, PROMOTE, PROMOTE + PROMOTE RF, PR (P030054/S235) | ABBOTT MEDICAL | 2012-10-31 |
| WALLSTENT ENDO (VENOUS) STENT SYTEM (P980033/S026) | Boston Scientific Corporation | 2012-10-31 |
| FRONTIER, FRONTIER II, ANTHEM FAMILY OF CRT-PS (P030035/S105) | ABBOTT MEDICAL | 2012-10-31 |
| PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES (P880087/S020) | Alcon Laboratories | 2012-10-31 |
| PMMA MULTI-PEICE POSTERIOR CHAMBER INTRAOCULAR LENSES (P810032/S062) | Alcon Laboratories | 2012-10-31 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S035) | Boston Scientific Corp | 2012-10-31 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S181) | Medtronic, Inc. | 2012-10-31 |
| REVO MRI IPG (P090013/S076) | Medtronic, Inc. | 2012-10-31 |
| ADVISA DR IPG (P980035/S295) | Medtronic, Inc. | 2012-10-31 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S099) | Boston Scientific Scimed, Inc. | 2012-10-31 |
| ACRYSOF MONFOCAL AND ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENSES AND ACRYSERT DELIVERY SYSTEM (P930014/S064) | Alcon Laboratories, Inc. | 2012-10-31 |
| ATLAS/ATLAS+, ATLAS II/ATLAS 11+ CURRENT, CURRENT ACCEL, CURRENT+ EPIC/EPIC+, EPIC II/EPIC II+, FORTIFY, FORTFY ASSURA, (P910023/S306) | ABBOTT MEDICAL | 2012-10-31 |
| STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION (P990071/S016) | Biosense Webster, Inc. | 2012-10-31 |
| WALLSTENT REDUCED PROFILE STENT SYSTEM (P940019/S032) | Boston Scientific Scimed, Inc. | 2012-10-31 |
| IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF DE PACERS (P880086/S227) | ABBOTT MEDICAL | 2012-10-31 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S056) | Boston Scientific Corp | 2012-10-31 |
| VNS THERAPY SYSTEM (P970003/S153) | LivaNova USA, Inc. | 2012-10-30 |
| FALOPE-RING CAND AND APPLICATOR SYSTEMS (P870076/S013) | Gyrus Acmi, Inc. | 2012-10-26 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S008) | Medtronic Vascular | 2012-10-26 |
| GUARDIAN REAL-TIME MONITOR, MODEL CSS7100. CS7100K (P980022/S123) | Medtronic Minimed | 2012-10-26 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S046) | Intera Oncology | 2012-10-26 |
| ENTRUST,SECURA,GEM II/III VR/DR,INTRINSIC/INTRINSIC 30,MAXIMO VR/DR,MAXIMO II,MARQUIS VR/DR,PROTECTA/PROTECTA XT (P980016/S376) | Medtronic Cardiac Rhythm Disease Management | 2012-10-26 |
| CONCERTA, CONSULTA/CONSULTA DF4, & VARIOUS INSYNC FAMILIES OF ICD'S; CONCERTO II, MAXIMO II,PROTECTA,PROTECTA XT CRT-D'S (P010031/S329) | Medtronic Cardiac Rhythm Disease Management | 2012-10-26 |
| GEM III AT (P980050/S076) | Medtronic, Inc. | 2012-10-26 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S062) | Med-El Corp. | 2012-10-26 |
| CAPSURE, VITATRON CRYSTALINE, VITATRON EXCELLENCE PS (P830061/S080) | Medtronic Cardiac Rhythm Disease Management | 2012-10-26 |
| NUVASIVE PCM CERVICAL DISC SYSTEM (P100012) | Nuvasive, Inc. | 2012-10-26 |
| ATS 3F AORTIC BIOPROSTHESIS (P060025/S009) | Medtronic, Inc. | 2012-10-26 |
| ATTAIN STARFIX LEAD (P060039/S038) | Medtronic, Inc. | 2012-10-25 |
| TRANSVENE LEAD (P980050/S078) | Medtronic, Inc. | 2012-10-25 |
| CAPSUREFIX MRI LEAD (P090013/S075) | Medtronic, Inc. | 2012-10-25 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S050) | Medtronic Sofamor Danek USA, Inc. | 2012-10-25 |
| AATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD (P010015/S180) | Medtronic, Inc. | 2012-10-25 |
| EON NEUROSTIMULATION SYSTEM (P010032/S055) | ABBOTT MEDICAL | 2012-10-25 |
| CAPSURE LEADS (P890003/S261) | Medtronic, Inc. | 2012-10-25 |
| LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S034) | Alcon Laboratories, Inc. | 2012-10-25 |
| TRILOGY AB ACETABULAR SYSTEM (P040048/S017) | Zimmer, Inc. | 2012-10-25 |
| ATTAIN ABILITY LEADS (P080006/S045) | Medtronic, Inc. | 2012-10-25 |
| CAPSURE LEADS, VITATRON CRYSTALINE LEADS, VITATRON EXCELLENCE PS+ LEADS (P830061/S079) | Medtronic Cardiac Rhythm Disease Management | 2012-10-25 |
| NEXGEN LPS/LPS FLEX MOBILE KNEE (P060037/S017) | Zimmer, Inc. | 2012-10-25 |
| ANCHORING SLEEVE KIT, SELECTSECURE LEAD (P030036/S049) | Medtronic Cardiac Rhythm Disease Management | 2012-10-25 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE (P930039/S075) | Medtronic, Inc. | 2012-10-25 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S028) | Allergan | 2012-10-25 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE SVC LEAD, TUNNELLING TOOL (P920015/S097) | Medtronic, Inc. | 2012-10-25 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S045) | Medtronic, Inc. | 2012-10-25 |
| INFUSE BONE GRAFT (P050053/S026) | Medtronic, Inc. | 2012-10-25 |
| CAPSURE SP NOVUS LEADS, CAPSURE SP Z LEAD, CAPSURE Z NOVUSLEADS, IMPULSE II LEADS (P850089/S090) | Medtronic Cardiac Rhythm Disease Management | 2012-10-25 |
| INFUSE BONE GRAFT (P000054/S035) | Medtronic Sofamor Danek USA, Inc. | 2012-10-25 |
| INTERSTIM (P970004/S143) | Medtronic Neuromodulation | 2012-10-24 |
| CELSIUS DS CATHETER AND NAVI-STAR DS CATHETER (P010068/S030) | Biosense Webster, Inc. | 2012-10-24 |
| WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S025) | Boston Scientific Corporation | 2012-10-24 |
| WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S031) | Boston Scientific Scimed, Inc. | 2012-10-24 |
| PUNTUA, COGNIS, ENERGEN, AND INCEPTA CRT-D'S (P010012/S305) | Boston Scientific Corp | 2012-10-24 |
| ITREL 3, SYNERGY, SYNERGY VERSITREL, ITREL 4 (P840001/S228) | Medtronic Neuromodulation | 2012-10-24 |
| WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S036) | Boston Scientific Corp | 2012-10-24 |
| CELSIUS CATHETERS (P950005/S040) | Biosense Webster, Inc. | 2012-10-24 |
| COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) (P010012/S306) | Boston Scientific Corp | 2012-10-24 |
| MODEL 3120 ZOOM LATTITUDE PROGRAMMING SYSTEM (P910077/S124) | Boston Scientific | 2012-10-24 |
| INTERSTIM (P080025/S039) | Medtronic Neuromodulation | 2012-10-24 |
| PUNCTUA, TELIGEN, ENERGEN, AND INCEPTA ICD'S (P960040/S273) | Boston Scientific | 2012-10-24 |
| TELIGEN IMPLANTABLE CARDIAC DEFIBRILLATORS (P960040/S274) | Boston Scientific | 2012-10-24 |
| GENESYS HTA SYSTEM (P000040/S025) | Axora Medical, Inc. | 2012-10-24 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S030) | Boston Scientific Corp | 2012-10-24 |
| VENTAK PRX AND VENTAK. MINI AUTOMATIC IMPLANTABLE CARDIOVERTER (P910077/S125) | Boston Scientific | 2012-10-24 |
| VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S011) | Siemens Healthcare Diagnostics, Inc. | 2012-10-24 |
| SOLETRA, KINETRA, ACTIVA SC (P960009/S158) | Medtronic, Inc. | 2012-10-24 |
| NAVI-STAR CATHETERS (P990025/S034) | Biosense Webster, Inc. | 2012-10-24 |
| CELSIUS THERMOCOOL CATHETERS (P030031/S048) | Biosense Webster, Inc. | 2012-10-24 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S055) | Boston Scientific Corp | 2012-10-24 |
| DEXCOM SEVEN CONTINUOUS GLUCOSE SYSTEM, DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING (P050012/S049) | Dexcom, Inc. | 2012-10-23 |
| ULTRA AND ZETA RX CORONARY STENT SYSTEMS (P970020/S075) | Abbott Vascular, Inc. | 2012-10-23 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S017) | Boston Scientific Corporation | 2012-10-23 |