| CAPSUREFIX NOVUS LEAD, 4076, CAPSUREFIX NOVUS LEAD, 5076 (P930039/S072) | Medtronic, Inc. | 2012-10-04 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD (P080006/S006) | Medtronic, Inc. | 2012-10-04 |
| ADAPTA/VERSA/SENSIA IPG (P980035/S223) | Medtronic, Inc. | 2012-10-04 |
| AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, AO60, M160 (P060022/S014) | Bausch & Lomb, Inc. | 2012-10-04 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON CABAS E 411 (P090007/S010) | Roche Diagnostics Corp. | 2012-10-04 |
| CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS (P870077/S047) | Edwards Lifesciences, LLC | 2012-10-04 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S028) | Bard Peripheral Vascular | 2012-10-04 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S335) | Medtronic Cardiac Rhythm Disease Management | 2012-10-04 |
| EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS (P000007/S034) | Edwards Lifesciences, LLC | 2012-10-04 |
| CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS (P870056/S052) | Edwards Lifesciences, LLC | 2012-10-04 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S383) | Medtronic Cardiac Rhythm Disease Management | 2012-10-04 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, ADVISA DR IPG, RELIA IPG (P980035/S292) | Medtronic, Inc. | 2012-10-04 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E170 (P090009/S010) | Roche Diagnostics Corp. | 2012-10-04 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S178) | Medtronic, Inc. | 2012-10-04 |
| ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 (P090008/S011) | Roche Diagnostics Corp. | 2012-10-04 |
| CAPSURE SENSE BIPOLAR LEAD (P830061/S064) | Medtronic Cardiac Rhythm Disease Management | 2012-10-04 |
| CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS (P010041/S036) | Edwards Lifesciences, LLC | 2012-10-04 |
| STRATOS LV/LV-T (P070008/S031) | Biotronik, Inc. | 2012-10-03 |
| SPRINT QUATTRO, SPRINT QUATTRO LEAD (P920015/S095) | Medtronic, Inc. | 2012-10-03 |
| FLEXTEND BIPOLAR ELUTING EXTENDABLE/RETRACTABLE PACING LEADS,MODELS 4086, 4087, 4088 (P960006/S035) | Boston Scientific | 2012-10-03 |
| BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S049) | Biotronik, Inc. | 2012-10-03 |
| VARIOUS FAMILIES OF PHILOS, CYLOS, EVIA, ENTOVIS, ESTELLA, ECURO, & EFFECTA IMPLANTABLE PACEMAKERS (P950037/S105) | Biotronik, Inc. | 2012-10-03 |
| CAPSURE, VITATRON CRYSTALINE, VISTATRON EXCELLENCE PS+ (P830061/S078) | Medtronic Cardiac Rhythm Disease Management | 2012-10-03 |
| ATTAIN BIPOLAR OTW LEAD, 4194 AND LEFT VENTRICULAR PACING LEAD, 4193 (P010015/S176) | Medtronic, Inc. | 2012-10-03 |
| TRANSVENE LEAD (P980050/S077) | Medtronic, Inc. | 2012-10-03 |
| ATTAIN STARFIX LEAD, 4195 (P060039/S036) | Medtronic, Inc. | 2012-10-03 |
| ACUITY STEERALE LEADS MODELS: 4554, 4555 (P050046/S016) | Guidant Corp. | 2012-10-03 |
| EASYTRAK 2 LV-1, IS-1, 3 LV-1, 3 IS-1 LEFT VENTRICLAR HEART FAILURE LEADS, AND ACUITY SPIRAL LEADS (P010012/S302) | Boston Scientific Corp | 2012-10-03 |
| KRONOS LV-T CRT-D AND LUMAX 300/340 & 500/540 CRT-D'S & ICD'S (P050023/S053) | Biotronik, Inc. | 2012-10-03 |
| ENDOTAK RELIANCE EZ IS-1 AND 4-SITE EZ QUADRIPOLAR ACTIVE FIXATION LEADS (P910073/S106) | Boston Scientific | 2012-10-03 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S043) | Medtronic, Inc. | 2012-10-03 |
| ATTAIN ABILITY LEADS (P080006/S044) | Medtronic, Inc. | 2012-10-03 |
| SELECTSECURE LEAD, 3830 (P030036/S047) | Medtronic Cardiac Rhythm Disease Management | 2012-10-03 |
| ADAPTA/RELIA/SENSIA/VERSA (P980035/S252) | Medtronic, Inc. | 2012-10-03 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEADS (P930039/S073) | Medtronic, Inc. | 2012-10-03 |
| THINLINE II AND FINELINE II STEROX LEADS AND FINELINE II EZ STEROX LEADS (P960004/S055) | Boston Scientific | 2012-10-03 |
| CONCEPTUS ESSURE SYSTEM (P020014/S038) | Bayer Pharma AG | 2012-10-02 |
| MELAFIND (P090012/S002) | Strata Skin Sciences, Inc. | 2012-10-02 |
| UNIDIRECTIONAL THERMOCOOL SF NAV CATHETER (P030031/S045) | Biosense Webster, Inc. | 2012-10-02 |
| M-VU ALGOIRITHM ENGINE (P100005/S001) | Icad, Inc. | 2012-10-01 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S140) | Boston Scientific Corp | 2012-10-01 |
| CONSULTA CRT-P, C4TR01, SYNCRA CRT-P C2TR01 (P010015/S177) | Medtronic, Inc. | 2012-10-01 |
| ADVISA DR-IPG A4DR01 (P980035/S291) | Medtronic, Inc. | 2012-10-01 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S016) | Allergan | 2012-10-01 |
| PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM (P980052/S005) | Stryker Leibinger, GmbH & Co KG | 2012-10-01 |
| ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S043) | Cook, Inc. | 2012-10-01 |
| ESTEEM (P090018/S018) | Envoy Medical Corporation | 2012-09-28 |
| SECURE-C ARTIFICIAL CERVICAL DISC (P100003) | Globus Medical, Inc. | 2012-09-28 |
| COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS (P840062/S024) | Integra Lifesciences Corp. | 2012-09-28 |
| COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S035) | Integra LifeSciences Corporation | 2012-09-28 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042) | Boston Scientific Corporation | 2012-09-28 |
| HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S032) | Integra LifeSciences Corporation | 2012-09-28 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S030) | Bard Peripheral Vascular, Inc. | 2012-09-27 |
| ABBOTT REALTIME HCV (P100017/S002) | Abbott Molecular, Inc. | 2012-09-27 |
| E-LUMINEXX VASCULAR STENT (P080007/S011) | Bard Peripheral Vascular, Inc. | 2012-09-27 |
| EXPRESS2 MONORAIL AND OTW CORONARY STENT SYSTEM (P020009/S088) | Boston Scientific Scimed, Inc. | 2012-09-27 |
| BIOFINITY (COMFILCON A) SOFT CONTACT LENSES (P080011/S017) | CooperVision, Inc. | 2012-09-27 |
| IOPN PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S053) | Boston Scientific Corp | 2012-09-27 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S030) | Boston Scientific Corp | 2012-09-27 |
| GORE HELIX SEPTAL OCCLUDER, HX2015, HX2020, HX2025, HX2090, HX2095 (P050006/S031) | W. L. Gore & Associates, Inc. | 2012-09-27 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S011) | Exactech, Inc. | 2012-09-27 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P110010/S028) | Boston Scientific Corp | 2012-09-27 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S091) | Boston Scientific Scimed, Inc. | 2012-09-27 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S024) | Bard Peripheral Vascular | 2012-09-27 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S142) | Boston Scientific Corp | 2012-09-26 |
| ABBOTT REALTIME HBV ASSAY (P080026/S003) | Abbott Molecular, Inc. | 2012-09-26 |
| KAPPA,SIGMA,ADAPTA,SENSA,ADVISA,REVO MRI,ENRHYTHM MRI,RELIA,VERSA,AND ENPULSE FAMILIES OF IPGS (P980035/S290) | Medtronic, Inc. | 2012-09-25 |
| CONCERTO,MAXIMO,CONSULTA,INSYNC SENTRY,MARQUIS,VIRTUOSO,SECURA,AND PROTECTA FAMILIES OF ICDS (P010031/S334) | Medtronic Cardiac Rhythm Disease Management | 2012-09-25 |
| RADIESSE (P050052/S036) | Merz North America, Inc. | 2012-09-25 |
| REVO MRI,AND ENRHYTHM MRI FAMILIES OF IPGS (P090013/S072) | Medtronic, Inc. | 2012-09-25 |
| LATTITUDE PATIENT MANAGEMENT SYSTEM (P910077/S123) | Boston Scientific | 2012-09-25 |
| ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM (P100021/S020) | Medtronic Vascular | 2012-09-25 |
| SYNERGYST,ELITE,MINUET,PRELUDE,THERA,PRODIGY,PREVA, J EWEL,AND REVEAL FAMILIES OF IPGS (P890003/S258) | Medtronic, Inc. | 2012-09-25 |
| INSYNC,CONSULTA,AND SYNCRA FAMILIES OF IPGS (P010015/S175) | Medtronic, Inc. | 2012-09-25 |
| VIRTUOSO,ENTRUST,MAXIMO,INTRINSIC,MARQUIS,CONCERTO,PROTECTA,SECURA,CONSULTA,GEM,AND ONYX FAMILIES OF ICDS (P980016/S381) | Medtronic Cardiac Rhythm Disease Management | 2012-09-25 |
| RADIESSE (P050037/S033) | Merz North America, Inc. | 2012-09-25 |
| VITAPREP PLASMA SEPERATOR (P050044/S023) | Stryker Corp. | 2012-09-25 |
| LINOX SMART (P980023/S047) | Biotronik, Inc. | 2012-09-24 |
| TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S269) | Boston Scientific | 2012-09-24 |
| ATLAS HF,ATLAS II HF,ATLAS II,HF,EPIC,EPIC HF,EPIC,EPIC II HF,EPIC II HF,PROMOTE,PROMOTE,PROMOTE RF,PROMOTE ACCEL,UNIFY (P030054/S231) | ABBOTT MEDICAL | 2012-09-24 |
| IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF DEVICES (P880086/S225) | ABBOTT MEDICAL | 2012-09-24 |
| COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S299) | Boston Scientific Corp | 2012-09-24 |
| ATLAS/ATLAS,ATLAS II/ATLAS II,CURRENT,CURRENT ACCEL,CURRENT,EPIC/EPIC,EPIC II/EPIC II,FORTIFY,FORTIFY ASSURA,ELLIPSE (P910023/S303) | ABBOTT MEDICAL | 2012-09-24 |
| REOCOR S/D EXTERNAL PACEMAKER (P950037/S111) | Biotronik, Inc. | 2012-09-24 |
| FRONTIER, FRONTIER II, ANTHEM FAMILY OF DEVICES (P030035/S103) | ABBOTT MEDICAL | 2012-09-24 |
| OMNILINK ELITE VASCULAR BALLOON EXPANDABLE STENT SYSTEM (P110043/S002) | Abbott Vascular-Cardiac Therapies | 2012-09-24 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P110010/S029) | Boston Scientific Corp | 2012-09-21 |
| BLAZER PRIME XP TEMPERATURE ABLATION CATHETER (P020025/S035) | Boston Scientific | 2012-09-21 |
| CRYOBLATION CONSOLE (P100010/S018) | Medtronic Cryocath, LP | 2012-09-21 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S033) | Boston Scientific Corp | 2012-09-21 |
| EXPRESS CORONARY STENT SYSTEM (MONORAIL) (P020009/S091) | Boston Scientific Scimed, Inc. | 2012-09-21 |
| RX ACCULINK CARTOID STENT SYSTEM (P040012/S049) | Abbott Vascular | 2012-09-21 |
| TALENT ABDOMINAL STENT GRAFT (P070027/S035) | Medtronic Vascular | 2012-09-21 |
| EPIC VASCULAR SELF EXPANDING STENT SYSTEM (P110035/S003) | Boston Scientific Corp | 2012-09-21 |
| TAXUS LIBERTE PACILITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL) (P060008/S095) | Boston Scientific Corp | 2012-09-21 |
| WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S024) | Boston Scientific Corporation | 2012-09-21 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P100023/S054) | Boston Scientific Corp | 2012-09-21 |
| VERIFLEX BARE MAETAL CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P040016/S097) | Boston Scientific Scimed, Inc. | 2012-09-21 |
| TALENT THORACIC STENT GRAFT SYSTEM (P070007/S036) | Medtronic Vascular | 2012-09-21 |
| WALLSTENT TRANSJUGULAR PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS (P930031/S035) | Boston Scientific Corp | 2012-09-21 |