| CONSULTA AND SYNCRA CRT-PS (P010015/S164) | Medtronic, Inc. | 2012-07-25 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S014) | Corcym Canada Corp | 2012-07-25 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S033) | Baxter Healthcare Corp | 2012-07-25 |
| INCEPTA, COGNIS, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S289) | Boston Scientific Corp | 2012-07-25 |
| EXPRESS /EXPRESS MONORAIL CORONARY STENT SYSTEM (P020009/S089) | Boston Scientific Scimed, Inc. | 2012-07-25 |
| CONCERTO II CRT-D & VARIOUS FAMILIES OF MAXIMO II & PROTECTA CRT-DS' VARIOUS FAMILIES OF CONSULTA ICDS (P010031/S316) | Medtronic Cardiac Rhythm Disease Management | 2012-07-25 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S034) | Zoll Manufacturing Corporation | 2012-07-25 |
| X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S020) | Medtronic Sofamor Danek, Inc. | 2012-07-25 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS (P110013/S004) | Medtronic Vascular | 2012-07-25 |
| VIRTUOSO II DR/VR ICD & VARIOUS FAMILIES OF MAXIMO II, PROTECTA & SECURA ICDS (P980016/S364) | Medtronic Cardiac Rhythm Disease Management | 2012-07-25 |
| XACT CAROTID STENT SYSTEM (P040038/S024) | Abbott Vascular, Inc. | 2012-07-24 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S138) | Boston Scientific Corp | 2012-07-24 |
| DEXCOM SEVEN AND SEVEN PLUS SYSTEM (P050012/S039) | Dexcom, Inc. | 2012-07-24 |
| PATHWAY ANTI-C-KIT (9.7) REBBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S003) | Ventana Medical Systems, Inc. | 2012-07-24 |
| NATRELLE SALINE-FILLED BREAST IMPLANTS (P990074/S024) | Allergan | 2012-07-23 |
| DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S051) | Alcon Laboratories | 2012-07-23 |
| MAXIMO II, PROTECTA,PROTECTA XT, SECURA AND VIRTUOSO II (P980016/S314) | Medtronic Cardiac Rhythm Disease Management | 2012-07-23 |
| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S039) | Alcon Research, Ltd. | 2012-07-23 |
| VNS THERAPY SYSTEM (P970003/S148) | LivaNova USA, Inc. | 2012-07-23 |
| CELSIUS THERMOCOOL CATHETER (P030031/S043) | Biosense Webster, Inc. | 2012-07-23 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S027) | Allergan | 2012-07-23 |
| CONCERTO II. CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT (P010031/S268) | Medtronic Cardiac Rhythm Disease Management | 2012-07-23 |
| DERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE (P000036/S013) | Shire Regenerative Medicine | 2012-07-23 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S019) | Boston Scientific Corp | 2012-07-20 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S004) | Cordis US Corporation | 2012-07-20 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S035) | Biomet Manufacturing Corp | 2012-07-19 |
| TRANSVENE SVC LEAD (P920015/S090) | Medtronic, Inc. | 2012-07-18 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S017) | Allergan | 2012-07-18 |
| TRANSVENE LEADS (P980050/S072) | Medtronic, Inc. | 2012-07-18 |
| SELECTSECURE LEAD, 3830 (P030036/S044) | Medtronic Cardiac Rhythm Disease Management | 2012-07-18 |
| EPICARDIAL PATCH LEADS (P900061/S113) | Medtronic Cardiac Rhythm Disease Management | 2012-07-18 |
| THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS (P960004/S052) | Boston Scientific | 2012-07-18 |
| SURGIFLO HEMOSTATIC MATRIX (P990004/S022) | Ferrosan Meidcal Devices A/S | 2012-07-18 |
| ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR SYSTEM (P860008/S022) | Cardio Command | 2012-07-18 |
| MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S110) | Medtronic Minimed | 2012-07-17 |
| SIR-SPHERES (P990065/S006) | Sirtex Medical, Inc. | 2012-07-17 |
| PATH VYSION HER-2 DNA PROBE KIT ASSAY (P980024/S008) | Abbott Molecular, Inc. | 2012-07-17 |
| C-FLEX ASPHERIC INTRAOCULAR LENS (P060011/S004) | Rayner Intraocular Lenses , Ltd. | 2012-07-17 |
| BIOFINILITY (COMFILCON A) SOFT (HYDROPHYLIC) EXTENDED-WEAR CONTACT LENSES (P080011/S016) | CooperVision, Inc. | 2012-07-17 |
| ZENITH RENU AAA ANCILLARY GRAFT (P020018/S039) | Cook, Inc. | 2012-07-17 |
| INFUSE BONE GRAFT (P000054/S033) | Medtronic Sofamor Danek USA, Inc. | 2012-07-17 |
| ISERT MODEL PC-60AD PACKAGING IMPROVEMENT (P080004/S012) | Hoya Surgical Optics, Inc. | 2012-07-17 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S048) | Medtronic Sofamor Danek USA, Inc. | 2012-07-17 |
| STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) (P930016/S035) | Amo Manufacturing USA, LLC | 2012-07-17 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S137) | Boston Scientific Corp | 2012-07-17 |
| ENDOTAK LEAD SYSTEM (P910073/S103) | Boston Scientific | 2012-07-13 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S032) | Zoll Manufacturing Corporation | 2012-07-13 |
| STINGER, STINGER S, STINGER M, STINGER SM, SCORPION 2, SCORPION 2M ABLATION CATHETERS (P000020/S015) | Boston Scientific Corp | 2012-07-12 |
| ANTENNA AND PORTABLE CHARGER (P010032/S054) | ABBOTT MEDICAL | 2012-07-12 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S015) | Roche Molecular Systems, Inc. | 2012-07-12 |
| WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S022) | Boston Scientific Corporation | 2012-07-12 |
| WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S033) | Boston Scientific Corp | 2012-07-12 |
| FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/RETRACTABLE PACING LEADS (P960006/S034) | Boston Scientific | 2012-07-12 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S016) | Roche Molecular Systems, Inc. | 2012-07-12 |
| WALLSTENT IIIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S028) | Boston Scientific Scimed, Inc. | 2012-07-12 |
| ENDOTAK RELIANCE EZ IS-1 ACTIVE FIZATION LEAD MODELS (P910073/S104) | Boston Scientific | 2012-07-12 |
| WALLSTENT (VENOUS) ENDOPROSTHESIS (P980033/S021) | Boston Scientific Corporation | 2012-07-11 |
| METHAFILCON A AND METHAFILCON B SOFT HYDROPHILIC WEAR CONTACT LENSES INSTALLATION AND VALIDATION OF A NEW 3M ATTEST 290 (P850079/S053) | CooperVision, Inc. | 2012-07-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S012) | Edwards Lifesciences, LLC | 2012-07-11 |
| WALLSTENT (CAROTID) ENDOPROSTHESIS (P050019/S009) | Boston Scientific Corp | 2012-07-11 |
| AUTOMATED ACCELEROMETER TEST SYSTEM UPDATE (P980035/S274) | Medtronic, Inc. | 2012-07-11 |
| XACT CAROTID STENT SYSTEM (P040038/S027) | Abbott Vascular, Inc. | 2012-07-11 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S019) | Medtronic Vascular | 2012-07-11 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S030) | Abbott Vascular Devices | 2012-07-11 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S050) | Edwards Lifesciences, LLC | 2012-07-11 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S045) | Boston Scientific Corp | 2012-07-11 |
| ON-X PROSTHETIC HEART VALVE (P000037/S027) | On-X Life Technologies, Inc. | 2012-07-11 |
| ACCULINK CAROTID STENT SYSTEM (P040012/S048) | Abbott Vascular | 2012-07-11 |
| FLEXTOME CUTTING BALLOON (MONORAIL) (P950020/S051) | Boston Scientific Corp | 2012-07-11 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S096) | Abbott Vascular, Inc. | 2012-07-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSHESIS (P860057/S090) | Edwards Lifesciences, LLC | 2012-07-11 |
| WALLSTENT (TIPS) ENDOPROSTHESIS (P930031/S032) | Boston Scientific Corp | 2012-07-11 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (MONORAIL) (P110010/S017) | Boston Scientific Corp | 2012-07-11 |
| VERIFLEX CORONARY STENT SYSTEM (MONORAIL) (P040016/S089) | Boston Scientific Scimed, Inc. | 2012-07-11 |
| ATTAIN ABILITY (P080006/S041) | Medtronic, Inc. | 2012-07-11 |
| RX HERCULINK ELITE RENAL STENT SYSTEM (P110001/S007) | Abbott Vascular | 2012-07-11 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S024) | Abbott Vascular | 2012-07-11 |
| XACT CAROTID STENT SYSTEM (P040038/S026) | Abbott Vascular, Inc. | 2012-07-11 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S045) | Edwards Lifesciences, LLC | 2012-07-11 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S032) | Edwards Lifesciences, LLC | 2012-07-11 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S002) | Boston Scientific Corp | 2012-07-11 |
| HERCULINK ELITE PERIPHERAL STENT SYSTEM (P110001/S006) | Abbott Vascular | 2012-07-11 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CHRONIUM CORONARY STENT SYSTEM (P110010/S016) | Boston Scientific Corp | 2012-07-11 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL) (P060008/S090) | Boston Scientific Corp | 2012-07-11 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S004) | Abbott Vascular, Inc. | 2012-07-11 |
| WALLSTENT (IIIAC) ENDOPROSTHESIS (P940019/S027) | Boston Scientific Scimed, Inc. | 2012-07-11 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S034) | Edwards Lifesciences, LLC | 2012-07-11 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL) (P100023/S046) | Boston Scientific Corp | 2012-07-11 |
| ACCULINK, RX SELF-EXPANDING CARTOID STENT SYSTEM (P040012/S047) | Abbott Vascular | 2012-07-11 |
| SAFIRE BLU SP ABLATION CATHETER, THERAPY COOL PATH SP (BI-DIRECTIONAL) ABLATION CATHETER (P060019/S021) | Irvine Biomedical, Inc. | 2012-07-10 |
| SAFIRE BLU DUO SP ABLATION CATHETERS (P110016/S002) | ABBOTT MEDICAL | 2012-07-10 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S136) | Boston Scientific Corp | 2012-07-10 |
| PRODISC-L TOTAL DISC REPLACEMENT (P050010/S012) | Centinel Spine, LLC | 2012-07-10 |
| COOPERVISION BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P080011/S014) | CooperVision, Inc. | 2012-07-09 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S116) | Boston Scientific Corp | 2012-07-06 |
| EPIC HF/ATLAS+HF/QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S224) | ABBOTT MEDICAL | 2012-07-06 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S098) | Boston Scientific Corp | 2012-07-06 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S097) | ABBOTT MEDICAL | 2012-07-06 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S015) | Boston Scientific Corp | 2012-07-06 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S080) | St. Jude Medical, Inc. | 2012-07-06 |