| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S057) | W. L. Gore & Associates, Inc. | 2013-10-25 |
| REFLECTION CERAMIC HIP SYSTEM (P030022/S026) | Smith & Nephew, Inc. | 2013-10-25 |
| ADAPTA,VERSA,SENSIA IPG,RELIA IPG (P980035/S348) | Medtronic, Inc. | 2013-10-25 |
| PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S020) | Ventana Medical Systems, Inc. | 2013-10-25 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S029) | Medtronic Vascular | 2013-10-25 |
| SELECTSECURE LEAD (P030036/S063) | Medtronic Cardiac Rhythm Disease Management | 2013-10-25 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S019) | DePuy Orthopaedics, Inc. | 2013-10-24 |
| RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S026) | Medtronic Vascular | 2013-10-24 |
| HANCOCK LOW POROSITY VALVED CONDUIT, MODEL 105 (P870078/S023) | Medtronic, Inc. | 2013-10-24 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S022) | Boston Scientific Corp | 2013-10-24 |
| COAPTITE INJECTABLE IMPLANT (P040047/S028) | Merz North America, Inc. | 2013-10-24 |
| INTEGRITY RX CORONARY STENT SYSTEM,INTEGRITY OTW CORONARY STENT SYSTEM (P030009/S068) | Medtronic, Ireland | 2013-10-24 |
| RADIESSE (P050052/S044) | Merz North America, Inc. | 2013-10-24 |
| RADIESSE (P050037/S041) | Merz North America, Inc. | 2013-10-24 |
| MITRACLIP DELIVERY SYSTEM (P100009) | ABBOTT MEDICAL | 2013-10-24 |
| COAPTITE INJECTABLE IMPLANT (P040047/S029) | Merz North America, Inc. | 2013-10-24 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S081) | Medtronic, Inc. | 2013-10-24 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S105) | Cochlear Americas | 2013-10-23 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S069) | Medtronic, Ireland | 2013-10-23 |
| SNS URINARY PROGRAMMING SYSTEMS, N VISION PROGRAMMER (P970004/S160) | Medtronic Neuromodulation | 2013-10-23 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S082) | Medtronic, Inc. | 2013-10-23 |
| DRUG DELIVERY PROGRAMMING SYSTEMS, N VISION PROGRAMMER (P860004/S196) | Medtronic, Inc. | 2013-10-23 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S221) | Medtronic, Inc. | 2013-10-23 |
| ADAPTA,VERSA,SENSIA IPG, ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG (P980035/S347) | Medtronic, Inc. | 2013-10-23 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS (P110013/S027) | Medtronic Vascular | 2013-10-23 |
| BRAVA CRT-D,CONCERTO II CRT-D, CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S403) | Medtronic Cardiac Rhythm Disease Management | 2013-10-23 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S019) | Boston Scientific Corp | 2013-10-23 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECT XT ICD,SECURA ICD (P980016/S442) | Medtronic Cardiac Rhythm Disease Management | 2013-10-23 |
| SCS PROGRAMMING SYSTEMS, N VISION PROGRAMMER (P840001/S250) | Medtronic Neuromodulation | 2013-10-23 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S043) | Boston Scientific Corp | 2013-10-23 |
| BLAZER IIXP/BLAZER PRIME XP ABLATION CATHETERS AND EPT-1000 XP CARDIAC ABLATION CONTROLLER (P020025/S048) | Boston Scientific | 2013-10-23 |
| SNS BOWEL PROGRAMMING SYSTEMS, N VISION PROGRAMMER (P080025/S056) | Medtronic Neuromodulation | 2013-10-23 |
| DBS PROGRAMMING SYSTEMS, N VISION PROGRAMMER, ACCESS THERAPY CONTROLLER, ACCESS REVIEW THERPY CONTROLLER (P960009/S181) | Medtronic, Inc. | 2013-10-23 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S104) | Cochlear Americas | 2013-10-23 |
| REVO MRI IPG (P090013/S115) | Medtronic, Inc. | 2013-10-23 |
| CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S018) | DePuy Orthopaedics, Inc. | 2013-10-23 |
| BLAZER II/ BLAZER PRIME HTD ABLATION CATHETERS (P920047/S062) | Boston Scientific Corp | 2013-10-23 |
| JUVEDERM VOLUMA XC (P110033) | Allergan | 2013-10-22 |
| ZILVER PTX DRUG ELUTING PERIPHERAL STENT (P100022/S008) | Cook Ireland, Ltd. | 2013-10-22 |
| DBS ACCESSORIES; EXTENSION ;NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY; KINETRA FAMILY, DBS SCREEING SYSTEM (P960009/S182) | Medtronic, Inc. | 2013-10-22 |
| SNS URINARY ACCESSORIES, EXTENSION, LEADS URINRY NEUROSTIMULATOR IMPLANTABLE INTERSTRIM FAMILY, URINARY SCREENING TRIAL (P970004/S161) | Medtronic Neuromodulation | 2013-10-22 |
| TEST STIMULATION LEAD BULK ACCESSORY,TEST STIMULATION LEAD KIT (P970004/S155) | Medtronic Neuromodulation | 2013-10-22 |
| SCS ACCESSORIES (P840001/S251) | Medtronic Neuromodulation | 2013-10-22 |
| PIPELINE EMBOLIZATION DEVICE (P100018/S008) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2013-10-22 |
| SNS BOWEL ACCESSIRUES, EXTENSION , LEADS NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY, SCREENING TRIALING SYSTEMS (P080025/S057) | Medtronic Neuromodulation | 2013-10-22 |
| TEST STIMULATION LEAD BULK ACCESSORY,TEST STIMULATION LEAD KIT (P080025/S051) | Medtronic Neuromodulation | 2013-10-22 |
| DRUG DELIVERY CATHETERS, DRUG DELIVERY INFUSION PUMP SYNCHROMED FAMILY, DRUG DELIVERY KITS FOR REVISIONS (P860004/S197) | Medtronic, Inc. | 2013-10-22 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005) | Cardiovascular Systems, Inc. | 2013-10-21 |
| GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE (P040037/S050) | W. L. Gore & Associates, Inc. | 2013-10-18 |
| CORONARY FLEXTOME CUTTING BALLON (P950020/S065) | Boston Scientific Corp | 2013-10-18 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S128) | Boston Scientific Corp | 2013-10-18 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S127) | Boston Scientific Corp | 2013-10-18 |
| ION CORONARY STENT SYSTEM (P100023/S079) | Boston Scientific Corp | 2013-10-18 |
| WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P020050/S014) | Alcon Laboratories, Inc. | 2013-10-18 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S012) | Dexcom, Inc. | 2013-10-18 |
| WALLSTENT (TIPS) ENDOPROSTHESIS (P930031/S048) | Boston Scientific Corp | 2013-10-18 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S061) | Boston Scientific Corp | 2013-10-18 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S028) | Boston Scientific Corporation | 2013-10-18 |
| ARCHITECT HBSAG QUALITATIVE CONFIRMATORY , LN 4P54 (P110029/S013) | Abbott Laboratories | 2013-10-18 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S078) | Boston Scientific Corp | 2013-10-18 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S111) | Boston Scientific Scimed, Inc. | 2013-10-18 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S047) | Boston Scientific | 2013-10-18 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S042) | Boston Scientific Corp | 2013-10-18 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S062) | Boston Scientific Corp | 2013-10-18 |
| WALLSTENT (VENOUS) ENDOPROSTHESIS (P980033/S037) | Boston Scientific Corporation | 2013-10-18 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S110) | Boston Scientific Scimed, Inc. | 2013-10-18 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S061) | Boston Scientific Corp | 2013-10-18 |
| EXPRESS SD RENAL MONRAIL PREMOUNTED STENT SYSTEM (P060006/S050) | Boston Scientific Corp | 2013-10-18 |
| WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P030008/S012) | Alcon Laboratories, Inc. | 2013-10-18 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S018) | Boston Scientific Corp | 2013-10-18 |
| ARCHITECT AUSAB LN 1L82 (P050051/S022) | Abbott Laboratories, Inc. | 2013-10-18 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S049) | Boston Scientific Corp | 2013-10-18 |
| WALLSTENT (LLIAC) ENDOPROSTHESIS (P940019/S041) | Boston Scientific Scimed, Inc. | 2013-10-18 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S021) | Boston Scientific Corp | 2013-10-18 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S117) | Boston Scientific Scimed, Inc. | 2013-10-18 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S116) | Boston Scientific Scimed, Inc. | 2013-10-18 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S020) | Boston Scientific Corp | 2013-10-18 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S007) | Ortho-Clinical Diagnostics, Inc. | 2013-10-17 |
| CAPSURE LEAD (P890003/S288) | Medtronic, Inc. | 2013-10-17 |
| ATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD (P010015/S222) | Medtronic, Inc. | 2013-10-17 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S052) | Medtronic, Inc. | 2013-10-17 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S024) | Beckman Coulter, Inc. | 2013-10-17 |
| HANCOCK II BIOPROSTHETIC HEART VALVE (P980043/S044) | Medtronic, Inc. | 2013-10-17 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S025) | Beckman Coulter, Inc. | 2013-10-17 |
| CAPSURE SP Z LEAD (P850089/S101) | Medtronic Cardiac Rhythm Disease Management | 2013-10-17 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S035) | Beckman Coulter, Inc. | 2013-10-17 |
| CAPSURE SENSE LEAD,CAPSURE SP NOVUS LEAD,VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+ LEAD (P830061/S098) | Medtronic Cardiac Rhythm Disease Management | 2013-10-17 |
| TRANSVENE CS/SVC LEAD (P980050/S085) | Medtronic, Inc. | 2013-10-17 |
| SPRINT QUATTRO LEAD (P920015/S119) | Medtronic, Inc. | 2013-10-17 |
| DEFLUX INJECTABLE GEL (P000029/S075) | Palette Life Sciences | 2013-10-17 |
| SELECTSECURE LEAD (P030036/S064) | Medtronic Cardiac Rhythm Disease Management | 2013-10-17 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S052) | Medtronic, Inc. | 2013-10-17 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR (P100001/S006) | Ortho-Clinical Diagnostics | 2013-10-17 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S025) | Beckman Coulter, Inc. | 2013-10-17 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S008) | Beckman Coulter, Inc. | 2013-10-17 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S009) | Beckman Coulter, Inc. | 2013-10-17 |
| OXFORD PARTIAL KNEE SYSTEM (P010014/S046) | Biomet Manufacturing Corp | 2013-10-17 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S030) | Medtronic | 2013-10-17 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S026) | Beckman Coulter, Inc. | 2013-10-17 |
| CAPSUREFIX NOVUS LEAD,VITATRON CRYSTALLINE LEAD (P930039/S094) | Medtronic, Inc. | 2013-10-17 |