| ROTATIONAL ATHERECTOMY SYSTEM (P900056/S104) | Boston Scientific Corp | 2011-08-31 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S070) | Cochlear Americas | 2011-08-30 |
| PIPELINE EMBOLIZATION DEVICE (P100018/S003) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2011-08-30 |
| MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR (P080025/S019) | Medtronic Neuromodulation | 2011-08-30 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S074) | Cochlear Americas | 2011-08-30 |
| REPLY/ESPRIT PACEMAKER IMPLANTABLE MEDICAL DEVICES (P950029/S061) | MicroPort CRM USA, Inc. | 2011-08-29 |
| MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S067) | Medtronic Minimed | 2011-08-29 |
| INTERSTIM THERAPY SYSTEMS (P970004/S125) | Medtronic Neuromodulation | 2011-08-26 |
| SYNCHROMED II IMPLANTABLE INFUSION PUMP/INDURA 1P INTRATHECAL/SUTURELESS PUMP CONNECTOR REVISION/PROXIMAL CATHETER (P860004/S157) | Medtronic, Inc. | 2011-08-26 |
| VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK (P110012) | Abbott Molecular, Inc. | 2011-08-26 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM (P080025/S018) | Medtronic Neuromodulation | 2011-08-26 |
| ASCENSION ORTHOPEDICS MCP (P000057/S006) | Smith & Nephew, Inc. | 2011-08-26 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S051) | Med-El Corp. | 2011-08-26 |
| VNS THERAPY SYSTEM (P970003/S117) | LivaNova USA, Inc. | 2011-08-26 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD (P840001/S195) | Medtronic Neuromodulation | 2011-08-26 |
| ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS (P960009/S125) | Medtronic, Inc. | 2011-08-26 |
| XIENCE NANO AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S078) | Abbott Vascular, Inc. | 2011-08-25 |
| MEDTRONIC CARELINK EXPRESS MONITORS, MODIFICATIONS T THE MEDTRONIC CARELINK REMOTE HOME MONITOR AND MEDTRONIC CARDIOSIGH (P890003/S228) | Medtronic, Inc. | 2011-08-25 |
| ROTABLATOR TOTATIONAL ATHERECTOMY SYSTEM (P900056/S108) | Boston Scientific Corp | 2011-08-25 |
| FREESTYLE AORIC ROOT BIOPROSTHESIS MODELS 995, 995CS AND 995MS (P970031/S034) | Medtronic, Inc. | 2011-08-25 |
| INTERSTIM SYSTEM (P080025/S013) | Medtronic Neuromodulation | 2011-08-25 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S032) | Medtronic, Inc. | 2011-08-25 |
| SOFTEC HD INTRAOCULAR LENS (P090022/S006) | Lenstec, Inc. | 2011-08-25 |
| HANCOCK I LOW POROSITY AND MIDIFIED ORIFICE VALVED CONDUIT MODEL 105 (P790007/S030) | Medtronic Heart Valves | 2011-08-25 |
| MOSIAC PORCINE BIOPROSTHESIS MODELS 305 AND 310 (P990064/S039) | Medtronic, Inc. | 2011-08-25 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S001) | Cordis US Corporation | 2011-08-25 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S087) | Boston Scientific Corp | 2011-08-25 |
| INTERSTIM SYSTEM (P970004/S121) | Medtronic Neuromodulation | 2011-08-25 |
| PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S073) | Abbott Vascular, Inc. | 2011-08-24 |
| MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION SYSTEM (P080025/S017) | Medtronic Neuromodulation | 2011-08-24 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S039) | W. L. Gore & Associates, Inc. | 2011-08-23 |
| QUANTIFERON-TB GOLD (P010033/S018) | Qiagen | 2011-08-23 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S064) | Abbott Vascular, Inc. | 2011-08-23 |
| ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM (P100010/S001) | Medtronic Cryocath, LP | 2011-08-23 |
| CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT (P010031/S271) | Medtronic Cardiac Rhythm Disease Management | 2011-08-19 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S082) | Cochlear Americas | 2011-08-19 |
| REVO MRI (P090013/S035) | Medtronic, Inc. | 2011-08-19 |
| MAXIMO II, PROTECTA, PROTECTA XT, SECURA VIRTUOSO II (P980016/S317) | Medtronic Cardiac Rhythm Disease Management | 2011-08-19 |
| INTERSTIM II, MODEL 3058 NEUROSTIMULATOR (P970004/S108) | Medtronic Neuromodulation | 2011-08-19 |
| SYNCRA CRT-P, CONSULTA CRT-P (P010015/S137) | Medtronic, Inc. | 2011-08-19 |
| ENRHYTHM (P980035/S239) | Medtronic, Inc. | 2011-08-19 |
| GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S017) | ETHICON, Inc. | 2011-08-18 |
| PRODISC -C TOTAL DISC REPLACEMENT (P070001/S011) | Centinel Spine, LLC | 2011-08-18 |
| TALENT THORACIC STENT GRAFT WITH THE XCELERANT AND CAPTIVIA DELIVERY SYSTEM (P070007/S029) | Medtronic Vascular | 2011-08-18 |
| ANEURX AAADVANTAGE STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM (P990020/S045) | Medtronic Vascular | 2011-08-18 |
| (D334TRG), PROTECTA XT (D314TRG) (P010031/S272) | Medtronic Cardiac Rhythm Disease Management | 2011-08-18 |
| DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S007) | Integra LifeSciences Corporation | 2011-08-18 |
| REPLY/ESPRIT (P950029/S060) | MicroPort CRM USA, Inc. | 2011-08-18 |
| NOVASURE IMPENDANCE CONROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S039) | Hologic, Inc. | 2011-08-18 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S004) | Medtronic Vascular | 2011-08-18 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S025) | Coloplast Corp. | 2011-08-18 |
| PERLANE L INJACTABLE GEL (P040024/S054) | Q-Med AB | 2011-08-18 |
| TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM (P070027/S029) | Medtronic Vascular | 2011-08-18 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II (P980016/S298) | Medtronic Cardiac Rhythm Disease Management | 2011-08-18 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM (P020025/S030) | Boston Scientific | 2011-08-18 |
| CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT (P010031/S252) | Medtronic Cardiac Rhythm Disease Management | 2011-08-18 |
| PROTECTA (D334TRG, D334VRG), PROTECTA XT (D314DRG, D314VRG) (P980016/S318) | Medtronic Cardiac Rhythm Disease Management | 2011-08-18 |
| FRONTIER/FRONTIER II / ANTHEM FAMILY OF CRT-PS (P030035/S086) | ABBOTT MEDICAL | 2011-08-17 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P080025/S015) | Medtronic Neuromodulation | 2011-08-17 |
| SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK (P990034/S024) | Medtronic, Inc. | 2011-08-17 |
| CADENCE/CURRENT/FORTIFY FAMILY OF ICDS (P910023/S267) | ABBOTT MEDICAL | 2011-08-17 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD (P840001/S193) | Medtronic Neuromodulation | 2011-08-17 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020) | Roche Molecular Systems, Inc. | 2011-08-17 |
| ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS (P960009/S124) | Medtronic, Inc. | 2011-08-17 |
| SYNCHROMED II IMPLANTABLE INFUSION PUMP/INDURA 1P INTRATHECAL/SUTURELESS PUMP CONNECTOR REVISION/PROXIMAL CATHETER (P860004/S155) | Medtronic, Inc. | 2011-08-17 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P080025/S014) | Medtronic Neuromodulation | 2011-08-17 |
| ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS (P960009/S123) | Medtronic, Inc. | 2011-08-17 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S041) | ABBOTT MEDICAL | 2011-08-17 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P970004/S122) | Medtronic Neuromodulation | 2011-08-17 |
| SYNCHROMED II IMPLANTABLE INFUSION PUMP/INDURA 1P INTRATHECAL/SUTURELESS PUMP CONNECTOR REVISION/PROXIMAL CATHETER (P860004/S156) | Medtronic, Inc. | 2011-08-17 |
| AMPLICOR HCV TEST (P000010/S019) | Roche Molecular Systems, Inc. | 2011-08-17 |
| EPIC HF/ATLAS + HF/PROMOTE/UNIFY FAMILY OF CRT-DS (P030054/S193) | ABBOTT MEDICAL | 2011-08-17 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD (P840001/S194) | Medtronic Neuromodulation | 2011-08-17 |
| WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S025) | Boston Scientific Scimed, Inc. | 2011-08-17 |
| INTERSTIM FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P970004/S123) | Medtronic Neuromodulation | 2011-08-17 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S207) | ABBOTT MEDICAL | 2011-08-17 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S072) | St. Jude Medical, Inc. | 2011-08-17 |
| ATTAIN STARFIX LEAD (P060039/S030) | Medtronic, Inc. | 2011-08-15 |
| LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S023) | Medtimo, Inc. | 2011-08-15 |
| VITATRON DA+C & VITATRON DA+T SERIES IPGS (P990001/S094) | Medtronic, Inc. | 2011-08-15 |
| REVO MRI (P090013/S033) | Medtronic, Inc. | 2011-08-15 |
| TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH) (P980050/S066) | Medtronic, Inc. | 2011-08-15 |
| CAPSURE, CAPSURE Z NOVUS, VARIOUS MODELS OF VITATRON (P850089/S083) | Medtronic Cardiac Rhythm Disease Management | 2011-08-15 |
| MODEL 4296 ATTAIN ABILITY PLUS LV LEAD AND MODEL 4396 ATTAIN ABILITY STRAIGHT LV LEAD (P080006/S034) | Medtronic, Inc. | 2011-08-15 |
| ADVISA, AT500, ENRHYTHM (P980035/S237) | Medtronic, Inc. | 2011-08-15 |
| CONCERTO/CONCERTO II, CONSULTA, VARIOUS INSYNC MODELS, MAXIMO II, PROTECTA/PROTECTA XT (P010031/S270) | Medtronic Cardiac Rhythm Disease Management | 2011-08-15 |
| CAPSURE, VITATRON CRYSTALLINE ACTFIX (P930039/S061) | Medtronic, Inc. | 2011-08-15 |
| Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS (P920015/S082) | Medtronic, Inc. | 2011-08-15 |
| 350 SERIES, ADAPTA, ADVISA, ENRHYTHM, RELIA, SENSIA, SIGMA, VERSA (P980035/S238) | Medtronic, Inc. | 2011-08-15 |
| ENTRUST, INSTRINSIC, MARQUIS, SECURA, VARIOUS MODELS OF MAXIMO, PROTECTA, & VIRTUOSO (P980016/S315) | Medtronic Cardiac Rhythm Disease Management | 2011-08-15 |
| RF CONDUCTR MC/RF CONTACTR/RF ENHANCR II/RF MARINR MC 7F/SC 5F/RF MARNIR UNIPOLAR/RF CONDUCTR MC ABLATION CATHETERS (P930029/S033) | Medtronic, Inc. | 2011-08-15 |
| SYNCRA CRT-P, CONSULTA CRT-P, INSYNC CRT-P, INSYNC III CRT-P (P010015/S135) | Medtronic, Inc. | 2011-08-15 |
| SELECTSECURE LEAD/SLEEVE KIT (P030036/S036) | Medtronic Cardiac Rhythm Disease Management | 2011-08-15 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S035) | Medtronic, Inc. | 2011-08-15 |
| CONCERTO/CONCERTOI II. CONSULTA, VARIOUS INSYNC MODELS, MAXIMO II, PROTECTA/PROTECTS XT (P010031/S269) | Medtronic Cardiac Rhythm Disease Management | 2011-08-15 |
| EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S195) | ABBOTT MEDICAL | 2011-08-15 |
| CAPSURE, VITATRON CRYSTALINE, & VITATRON EXCELLENCE +/PS+ (P830061/S071) | Medtronic Cardiac Rhythm Disease Management | 2011-08-15 |
| REVO MRI, CAPSURE FIX LEAD (P090013/S034) | Medtronic, Inc. | 2011-08-15 |
| DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1 (P900061/S108) | Medtronic Cardiac Rhythm Disease Management | 2011-08-15 |
| CAPSURE LEAD, CAPSURE MODEL LEAD, PRODIGY IPG (P890003/S234) | Medtronic, Inc. | 2011-08-15 |