| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S101) | Boston Scientific Corp | 2012-12-11 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS,THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMAFIX (P860057/S097) | Edwards Lifesciences, LLC | 2012-12-11 |
| AXSYM AFP (P820060/S031) | Abbott Laboratories | 2012-12-11 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S036) | Edwards Lifesciences, LLC | 2012-12-11 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S065) | Boston Scientific Corp | 2012-12-11 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S019) | Boston Scientific Corporation | 2012-12-11 |
| TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARD (P960040/S282) | Boston Scientific | 2012-12-11 |
| WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S028) | Boston Scientific Corporation | 2012-12-11 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S118) | Boston Scientific Corp | 2012-12-11 |
| OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S001) | Endologix, LLC | 2012-12-11 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S057) | Boston Scientific Corp | 2012-12-11 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S100) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S097) | Boston Scientific Scimed, Inc. | 2012-12-11 |
| MAXIMO II DF4 CRT-D, MAXIMO II DF4 ICD, MAXIMO II ICD, PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT (P980016/S391) | Medtronic Cardiac Rhythm Disease Management | 2012-12-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S016) | Edwards Lifesciences, LLC | 2012-12-10 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S037) | Edwards Lifesciences, LLC | 2012-12-10 |
| ARCHITECT ANTI-HCV (P050042/S020) | Abbott Laboratories, Inc. | 2012-12-10 |
| ARCHITECT HBSAG/CONFIRMATORY (P060007/S024) | Abbott Laboratories | 2012-12-10 |
| ARCHITECT CORE-M (P060035/S017) | Abbott Laboratories | 2012-12-10 |
| ARCHITECT CORE (P080023/S018) | Abbott Laboratories | 2012-12-10 |
| ARCHITECT AUSAB (P050051/S018) | Abbott Laboratories, Inc. | 2012-12-10 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S048) | Edwards Lifesciences, LLC | 2012-12-10 |
| CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROSTHESES (P870056/S053) | Edwards Lifesciences, LLC | 2012-12-10 |
| VARIOUS FAMILIES OF PERIMOUNT, RSR, THEON, RSR PERICARDIAL AORTIC BIOPROSTHESES & VARIOUS FAMILIES OF MAGNA, THEON, PLUS (P860057/S096) | Edwards Lifesciences, LLC | 2012-12-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S001) | Edwards Lifesciences, LLC | 2012-12-10 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S035) | Edwards Lifesciences, LLC | 2012-12-10 |
| ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY (P110029/S009) | Abbott Laboratories | 2012-12-10 |
| PROGEL PLEURAL AIR LEAK SEALANT (P010047/S024) | Neomend, Inc. | 2012-12-07 |
| BELOTERO BALANCE DERMAL FILTER (P090016/S003) | Merz North America, Inc. | 2012-12-07 |
| ARCHITECT TOTAL PSA (P910007/S038) | Abbott Laboratories | 2012-12-07 |
| ARCHITECT TOTAL PSA (P910007/S037) | Abbott Laboratories | 2012-12-07 |
| ARCHITECT FREE PSA (P980007/S028) | Abbott Laboratories | 2012-12-07 |
| ARCHITECT FREE PSA (P980007/S029) | Abbott Laboratories | 2012-12-07 |
| SYNCHROMED II INFUSION SYSTEM (P860004/S178) | Medtronic, Inc. | 2012-12-06 |
| VENTAK PRX AND VENTAK MINI ICD FANILIES (P910077/S129) | Boston Scientific | 2012-12-05 |
| AXSYM AUSAB (P060003/S012) | Abbott Laboratories, Inc. | 2012-12-05 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S037) | Abbott Vascular | 2012-12-05 |
| COSMOS (P830026/S081) | Boston Scientific | 2012-12-05 |
| VENTAK P2 ICD FAMILIES (P930035/S024) | Boston Scientific | 2012-12-05 |
| AXSYM HBSAG/HBSAG CONFIRMATORY (P050049/S011) | Abbott Laboratories, Inc. | 2012-12-05 |
| ARCHITECT HBSAG QUALITATIVE/HBSAG QUALITATIVE CONFIRMATORY (P110029/S008) | Abbott Laboratories | 2012-12-05 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S014) | Exactech, Inc. | 2012-12-05 |
| ARCHITECT AUSAB (P050051/S017) | Abbott Laboratories, Inc. | 2012-12-05 |
| VENTAK ICD FAMILIES (P890061/S022) | Boston Scientific | 2012-12-05 |
| AXSYM ANTI-HCV (P970027/S018) | Abbott Laboratories | 2012-12-05 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S001) | Boston Scientific Corporation | 2012-12-05 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S049) | W. L. Gore & Associates, Inc. | 2012-12-05 |
| SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEAD FAMILIES (P960006/S037) | Boston Scientific | 2012-12-05 |
| BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P080011/S019) | CooperVision, Inc. | 2012-12-05 |
| ARCHITECT CORE-M (P060035/S016) | Abbott Laboratories | 2012-12-05 |
| VIGOR DR/SR, DISCOVERY, MERIDIAN FAMILIES (P940031/S074) | Boston Scientific | 2012-12-05 |
| DELTA / VISTA FAMILIES (P840068/S052) | Boston Scientific | 2012-12-05 |
| SELUTE LEAD FAMILY (P950001/S025) | Boston Scientific | 2012-12-05 |
| ENDOTAK AND RELIANCE LEAD FAMILIES (P910073/S112) | Boston Scientific | 2012-12-05 |
| AXSYM CORE-M 2.0 (P060009/S007) | Abbott Laboratories, Inc. | 2012-12-05 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S104) | Abbott Vascular, Inc. | 2012-12-05 |
| ACUITY STEERABLE HEART FAILURE LEAD FAMILY (P050046/S018) | Guidant Corp. | 2012-12-05 |
| ARCHITECT CORE (P080023/S017) | Abbott Laboratories | 2012-12-05 |
| AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST (P940034/S019) | Gen-Probe, Inc. | 2012-12-05 |
| THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS (P960004/S058) | Boston Scientific | 2012-12-05 |
| MULTI-LINK 8, MULTI-LINK 8 SV AND MULTI-LINK 8 LL CORONARY STENT SYSTEM (CSS) (P020047/S053) | Abbott Vascular | 2012-12-05 |
| VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM FAMILY (P830060/S074) | Boston Scientific | 2012-12-05 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S076) | W. L. Gore & Associates, Inc. | 2012-12-05 |
| ARCHITECT ANTI-HCV (P050042/S019) | Abbott Laboratories, Inc. | 2012-12-05 |
| CONTAK RENEWAL TR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FAMILY (P030005/S093) | Guidant Corp. | 2012-12-05 |
| HER2 IQFISH PHARMDX (P040005/S007) | Agilent Technologies Singapore (International) Pte , Ltd. | 2012-12-05 |
| AXSYM CORE 2.0 (P060012/S010) | Abbott Laboratories, Inc. | 2012-12-05 |
| ARCHITECT HBSAG/HBSAG CONFIRMATORY (P060007/S023) | Abbott Laboratories | 2012-12-05 |
| CONTAK CD, LIVIAN, COGNIS, ENERGEN, PUNCTUA AND INCEPTA CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEFIBRILLATOR SYSTEMS (P010012/S314) | Boston Scientific Corp | 2012-12-05 |
| VENTAK AV, VENTAK PRIZM DR/VR, VITALITY, CONFIENT, AND TELIGEN, PUNCTUA, ENERGEN, AND INCEPTA ICD FAMILIES (P960040/S281) | Boston Scientific | 2012-12-05 |
| ACCENT, IDENTITY, IDENTITY ADX, INTEGRITY ADX, VERITY ADX, VICTORY, ZEPHER, MICRONY PACEMAKERS (P880086/S202) | ABBOTT MEDICAL | 2012-12-04 |
| REVO MRI IPG (P090013/S080) | Medtronic, Inc. | 2012-12-04 |
| ATLAS II/+, EPIC +/II/II+, CURRENT RF/+/ACCEL, FORTIFY ICDS (P910023/S263) | ABBOTT MEDICAL | 2012-12-04 |
| EON 16-CHANNEL IPG NEUROSTIMULATION SYSTEM, EON MINI IPG NEUROSTIMULATION SYSTEM (P010032/S064) | ABBOTT MEDICAL | 2012-12-04 |
| ANTHEM, FRONTIER II CRT-PS (P030035/S082) | ABBOTT MEDICAL | 2012-12-04 |
| DISPOSABLE PATIENT CABLES (P820003/S118) | Medtronic Cardiac Rhythm Disease Management | 2012-12-04 |
| ATLAS +HF, EPIC HF/+HF, PROMOTE RF/+/ACCEL, UNIFY CRT-DS (P030054/S188) | ABBOTT MEDICAL | 2012-12-04 |
| METHAFILCON A AND METHAFILCON B SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P850079/S062) | CooperVision, Inc. | 2012-12-04 |
| ADVISA DR IPG (P980035/S299) | Medtronic, Inc. | 2012-12-04 |
| MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, ECA MODULES M7, M8, M9 (P000025/S066) | Med-El Corp. | 2012-12-04 |
| NOVOTTF-100A SYSTEM (P100034/S002) | Novocure, GmbH | 2012-12-03 |
| SACRAL NERVE STIMULATION- BOWEL IMPLANTABLE NEUROSTIMULATORS (P080025/S035) | Medtronic Neuromodulation | 2012-12-03 |
| SPINAL CORD STIMULATION - IMPLANTABLE NEUROSTIMULATORS (P840001/S223) | Medtronic Neuromodulation | 2012-12-03 |
| STRATOS LV & STRATOS LV-T (P070008/S032) | Biotronik, Inc. | 2012-12-03 |
| DBS IMPLANTABLE NEUROSTIMULATORS (P960009/S152) | Medtronic, Inc. | 2012-12-03 |
| PHILOS, CYLOS, EVIA, ESTELLA, EFFECTA FAMILY IMPLANTABLE PULSE GENERATORS (P950037/S107) | Biotronik, Inc. | 2012-12-03 |
| SACRAL NERVE STIMULATION - URINARY IMPLANTABLE NEUROSTIMULATORS (P970004/S138) | Medtronic Neuromodulation | 2012-12-03 |
| ON-X PROSTHETIC HEART VALVE (P000037/S031) | On-X Life Technologies, Inc. | 2012-12-01 |
| ETI-CORE-IGMK PLUS ASSAY (P990044/S014) | DiaSorin, Inc. | 2012-11-30 |
| ETI-AB-EBK PLUS ASSAY (P990041/S016) | DiaSorin, Inc. | 2012-11-30 |
| ETI-MAK-2 PLUS ASSAY (P990038/S017) | DiaSorin, Inc. | 2012-11-30 |
| ETI-AB-AUK PLUS ASSAY (P990042/S013) | DiaSorin, Inc. | 2012-11-30 |
| ETI-EBK PLUS ASSAY (P990043/S017) | DiaSorin, Inc. | 2012-11-30 |
| COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES (P010012/S300) | Boston Scientific Corp | 2012-11-30 |
| TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES (P960040/S270) | Boston Scientific | 2012-11-30 |
| BRYAN CERVICAL DISC (P060023/S003) | Companion Spine France Sas | 2012-11-30 |
| GEL-ONE (P080020/S004) | Seikagaku Corp. | 2012-11-30 |
| ETI-AB-COREK PLUS ASSAY (P990045/S014) | DiaSorin, Inc. | 2012-11-30 |
| SAFIRE BLU DUO ABLATION CATHETERS (P110016/S005) | ABBOTT MEDICAL | 2012-11-29 |
| SAFIRE BLU AND THERAPY COOL BI-DIRECTIONAL ABLATION CATHETERS (P060019/S023) | Irvine Biomedical, Inc. | 2012-11-29 |