| FLEXTOME CUTTING BALLOON DILATATION DEVICE (MONORAIL & OVER-THE-WIRE) (P950020/S054) | Boston Scientific Corp | 2012-09-21 |
| CRYOCONSOLE, MODEL 106A3 (P020045/S045) | Medtronic Cryocath, LP | 2012-09-21 |
| BLAZER PRIME HTD TEMPERATURE ABLATION CATHETER (P920047/S053) | Boston Scientific Corp | 2012-09-21 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (MONORAIL) (P040016/S096) | Boston Scientific Scimed, Inc. | 2012-09-21 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P060008/S096) | Boston Scientific Corp | 2012-09-21 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038) | Bolton Medical, Inc. | 2012-09-21 |
| PROPEL MINI SINUS IMPLANT (P100044/S001) | Intersect Ent. | 2012-09-21 |
| WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S030) | Boston Scientific Scimed, Inc. | 2012-09-21 |
| EXPRESS2 CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P020009/S092) | Boston Scientific Scimed, Inc. | 2012-09-21 |
| IMAGECHECKER CAD (P970058/S025) | Hologic, Inc. | 2012-09-21 |
| VALIANT THORACIC STENT GRAFT (P100040/S009) | Medtronic Vascular | 2012-09-21 |
| LIFESTENT VASCULAR STENT SYSTEM (P070014/S034) | Bard Peripheral Vascular, Inc. | 2012-09-21 |
| LENSTEC SOFTEC HD PCIOL (P090022/S014) | Lenstec, Inc. | 2012-09-20 |
| MAXIMO II DF-4 CRT-D, MAXIMO II DF-4 ICD, MAXIMO II ICD, PROTECTA DF4-ICD, PROTECTA ICD, PROTECTA XT DF-4 ICD, PROTECTA (P980016/S379) | Medtronic Cardiac Rhythm Disease Management | 2012-09-20 |
| PROTECTA ICD, PROTECTA XT ICD (P980016/S380) | Medtronic Cardiac Rhythm Disease Management | 2012-09-20 |
| PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S333) | Medtronic Cardiac Rhythm Disease Management | 2012-09-20 |
| CONCERTO II CRT-D. CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF-4 CRT-D, PROTECTA CRT-D, PROTECTA DF4 (P010031/S332) | Medtronic Cardiac Rhythm Disease Management | 2012-09-20 |
| THERMOCOOL SF CATHETERS (BI-DIRECTIONAL), THERMOCOOL SF CATHETERS (UNI-DIRECTIONAL) (P030031/S047) | Biosense Webster, Inc. | 2012-09-20 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S003) | Cordis US Corporation | 2012-09-19 |
| ADAPTA ADSR01, ADSR03, ADSR06, RELIA RESO1, RESR01, SENSIA SES01, SESR01 (P980035/S288) | Medtronic, Inc. | 2012-09-19 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S094) | Abbott Vascular, Inc. | 2012-09-19 |
| CAPENTIER-EDWARDS S.A.V. BIOPROSTHESIS (P870077/S046) | Edwards Lifesciences, LLC | 2012-09-19 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S331) | Medtronic Cardiac Rhythm Disease Management | 2012-09-19 |
| CAPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S091) | Edwards Lifesciences, LLC | 2012-09-19 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S174) | Medtronic, Inc. | 2012-09-19 |
| ADVISA DR IPG (P980035/S289) | Medtronic, Inc. | 2012-09-19 |
| ATTAIN ABILITY LEADS, 4196, 4296, AND 4396 (P080006/S043) | Medtronic, Inc. | 2012-09-19 |
| CARPENTIER-EDWARDS S.A.V. NIOPROSTHESIS (P010041/S035) | Edwards Lifesciences, LLC | 2012-09-19 |
| PRODIGY, 8158 (P890003/S257) | Medtronic, Inc. | 2012-09-19 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S033) | Edwards Lifesciences, LLC | 2012-09-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S014) | Edwards Lifesciences, LLC | 2012-09-19 |
| XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S020) | Abbott Vascular | 2012-09-19 |
| CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS (P870056/S051) | Edwards Lifesciences, LLC | 2012-09-19 |
| ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (ONXAAP) (P000037/S029) | On-X Life Technologies, Inc. | 2012-09-19 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S378) | Medtronic Cardiac Rhythm Disease Management | 2012-09-19 |
| SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM) (P110006) | GE Healthcare | 2012-09-18 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S023) | Roche Molecular Systems, Inc. | 2012-09-18 |
| COBAS AMPLICOR HCV TEST, V2.0/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0 (P000012/S036) | Roche Molecular Systems, Inc. | 2012-09-18 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST/COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM, V2.0 (P060030/S024) | Roche Molecular Systems, Inc. | 2012-09-18 |
| SUPARTZ (P980044/S014) | Seikagaku Corp. | 2012-09-18 |
| SOF-SENSOR GLUCOSE SENSOR, MMT-7002, MMT-7003 (P980022/S122) | Medtronic Minimed | 2012-09-18 |
| COOPERVISION METHAFILCON AB EXTENDED WEAR CONTACT LENSES (P850079/S056) | CooperVision, Inc. | 2012-09-18 |
| GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S006) | Glaukos Corporation | 2012-09-18 |
| COPPERVISION METHAFILCON AB SOFT EXTENDED WEAR CONTACT LENSES (P850079/S055) | CooperVision, Inc. | 2012-09-18 |
| PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 (P010031/S305) | Medtronic Cardiac Rhythm Disease Management | 2012-09-17 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CHRONIUM CORONARY STENT SYSTEM (P110010/S024) | Boston Scientific Corp | 2012-09-17 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S049) | Boston Scientific Corp | 2012-09-17 |
| ABBOTT ARCHITECT HBSAG QUALITATIVE/ ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (P110029/S004) | Abbott Laboratories | 2012-09-14 |
| COBAS 4800 BRAF V600 MUTATION TEST (P110020/S005) | Roche Molecular Systems, Inc. | 2012-09-14 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S002) | Roche Molecular Systems, Inc. | 2012-09-14 |
| ACCENT FAMILY OF PACEMAKERS (P880086/S222) | ABBOTT MEDICAL | 2012-09-14 |
| XIENCE PRIME AND XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S009) | Abbott Vascular | 2012-09-14 |
| ANTHEM FAMILY OF PACEMAKERS (P030035/S100) | ABBOTT MEDICAL | 2012-09-14 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S141) | Boston Scientific Corp | 2012-09-14 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S034) | Integra LifeSciences Corporation | 2012-09-14 |
| COLLACOTE, COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS (P840062/S023) | Integra Lifesciences Corp. | 2012-09-14 |
| SPINAL CORD STIMULATION EXTENSION MODELS 37081, 37082 AND 37083 (P840001/S221) | Medtronic Neuromodulation | 2012-09-14 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST, HIGH PURE/COBAS TAQMAN HBV TEST (P050028/S026) | Roche Molecular Systems, Inc. | 2012-09-14 |
| EON MINI IPG NEUROSTIMULATION SYSTEM (P010032/S058) | ABBOTT MEDICAL | 2012-09-14 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S087) | Abbott Vascular, Inc. | 2012-09-14 |
| ABBOTT ARCHITECT HBSAG/ ARCHITECT HBS/AG CONFIRMATORY (P060007/S020) | Abbott Laboratories | 2012-09-14 |
| COBAS HPV TEST (P100020/S006) | Roche Molecular Systems, Inc. | 2012-09-14 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S031) | Integra LifeSciences Corporation | 2012-09-14 |
| COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST (P060030/S028) | Roche Molecular Systems, Inc. | 2012-09-14 |
| COBAS AMPLICOR HCV TEST, V2.0, COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S039) | Roche Molecular Systems, Inc. | 2012-09-14 |
| THERAPY COOL PATH DUO ABLATION CATHETER, SAFIRE BLU DUO ABLATION CATHETER AND 1500TP-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S001) | ABBOTT MEDICAL | 2012-09-13 |
| BRYAN CERVICAL DISC (P060023/S002) | Companion Spine France Sas | 2012-09-13 |
| INTERSTIM (P080025/S037) | Medtronic Neuromodulation | 2012-09-13 |
| TENDRIL FAMILY OF LEADS (P960013/S068) | ABBOTT MEDICAL | 2012-09-13 |
| GUARDIAN REAL-TIME SYSTEM, PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL PUMP (P980022/S121) | Medtronic Minimed | 2012-09-13 |
| SOLETRA, KINETRA, ACTIVA (P960009/S155) | Medtronic, Inc. | 2012-09-13 |
| ITREL, SYNERGEY, RESTOR (P840001/S226) | Medtronic Neuromodulation | 2012-09-13 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S006) | Infusyn Therapeutics, LLC | 2012-09-13 |
| VNS THERAPY PULSE GENERATOR, 102/102R (P970003/S152) | LivaNova USA, Inc. | 2012-09-13 |
| INTERSTIM (P970004/S140) | Medtronic Neuromodulation | 2012-09-13 |
| DURATA LEADS (P950022/S079) | ABBOTT MEDICAL | 2012-09-13 |
| CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM (P970029/S021) | Cryolife, Inc. | 2012-09-13 |
| DDMA SOFTWARE (P890003/S251) | Medtronic, Inc. | 2012-09-12 |
| TECNIS OPTIBLUE INTRAOCULAR LENS (IOL) MODEL ZV9003 & 1-PIECE IOL MODEL ZCB00V (P980040/S035) | Johnson & Johnson Surgical Vision, Inc. | 2012-09-12 |
| ACCENT FAMILY OF DEVICES (P880086/S224) | ABBOTT MEDICAL | 2012-09-12 |
| ANTHEM FAMILY OF DEVICES (P030035/S102) | ABBOTT MEDICAL | 2012-09-12 |
| LIFESTENT VASCULAR STENT SYSTEM (P070014/S033) | Bard Peripheral Vascular, Inc. | 2012-09-12 |
| MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S154) | Medtronic, Inc. | 2012-09-12 |
| RESTORE RECHARGEABLE,RESTORE PRIME,RESTORE,ADVANCED,PRIME ADVANCED,RESTORE ULTRA,ITREL 4,SYNERGY,SYNERGY VERSTIREL (P840001/S225) | Medtronic Neuromodulation | 2012-09-12 |
| MAXIMO II DF4 ICD, SECURA DF4 ICD (P980016/S362) | Medtronic Cardiac Rhythm Disease Management | 2012-09-12 |
| PUNTUA, INCEPTA AND ENERGEN CRT-D FAMILIES (P010012/S298) | Boston Scientific Corp | 2012-09-11 |
| PROMETRA PROGRAMMABLE IMPLANTABLE PUMP, 1031200 (P080012/S007) | Infusyn Therapeutics, LLC | 2012-09-11 |
| PUNTUA, INCEPTA AND ENERGEN ICD'S FAMILIES (P960040/S268) | Boston Scientific | 2012-09-11 |
| METHAFILCON A&B SOFT EXTENDED WEAR CONTACT LENSES (P850079/S054) | CooperVision, Inc. | 2012-09-11 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S018) | Smith & Nephew, Inc. | 2012-09-11 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, ENRHYTHM IPG, RELIA IPG (P980035/S287) | Medtronic, Inc. | 2012-09-10 |
| REVO MRI IPG, RVDR01 (P090013/S071) | Medtronic, Inc. | 2012-09-10 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S088) | Abbott Vascular, Inc. | 2012-09-10 |
| SAFIRE ABLATION SYSTEM (P960016/S039) | St Jude Medical | 2012-09-10 |
| PROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D (P010031/S314) | Medtronic Cardiac Rhythm Disease Management | 2012-09-10 |
| CARBOMEDICS PROSTHETIC HEART VLAVE (P900060/S049) | Corcym S.r.l. | 2012-09-10 |
| PRODIGY IPG 8158 (P890003/S256) | Medtronic, Inc. | 2012-09-10 |
| KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM (P050027/S004) | KARL STORZ Endoscopy-America, Inc. | 2012-09-10 |
| PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD (P980016/S361) | Medtronic Cardiac Rhythm Disease Management | 2012-09-10 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S011) | Abbott Vascular | 2012-09-10 |