| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) (P100023/S067) | Boston Scientific Corp | 2013-01-08 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S046) | Medtronic, Inc. | 2013-01-08 |
| THE SYNCHROMED II IMPLANTABLE PUMP (P860004/S182) | Medtronic, Inc. | 2013-01-08 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S034) | Medtronic Heart Valves | 2013-01-08 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) (P110010/S043) | Boston Scientific Corp | 2013-01-08 |
| ON-X PROSTHETIC HEART VALVE (P000037/S032) | On-X Life Technologies, Inc. | 2013-01-08 |
| DBS ACCESSORIES,DBS EXTENSIONS,DBS LEADS,DBS NEUROSTIMULATORS IMPLANTABLE,DBS NEUROSTIMULATORS SOLETRA FAMILY (P960009/S161) | Medtronic, Inc. | 2013-01-08 |
| DRUG DELIVERY ACCESSORIES,DRUG DELIVERY CATHETERS,DRUG DELIVERY INFUSION PUMPS SYNCHROMED FAMILY,DRUG DELIVERY KITS (P860004/S181) | Medtronic, Inc. | 2013-01-08 |
| SNS URINARY ACCESSORIES,SNS URINARY EXTENSIONS,SNS URINARY LEADS,SNS URINARY NEUOSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P970004/S147) | Medtronic Neuromodulation | 2013-01-08 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S101) | Edwards Lifesciences, LLC | 2013-01-08 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S038) | Medtronic, Inc. | 2013-01-08 |
| CVX-300 EXCIMER LASER SYSTEM (P910001/S063) | Spectranetics Corp. | 2013-01-08 |
| HANCOCK PORCINE BIOPROSTHESIS (P870078/S018) | Medtronic, Inc. | 2013-01-08 |
| HANCOCK II BIOPROSTHETIC HEART VALVE (P980043/S038) | Medtronic, Inc. | 2013-01-08 |
| SNS BOWEL ACCESSORIES,SNS BOWEL EXTENSIONS,SNS LEADS,SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY,SNS BOWEL (P080025/S043) | Medtronic Neuromodulation | 2013-01-08 |
| COBAS AMPLIPREP / COBAS TAQMAN CMV TEST, V2.0 (P110037/S003) | Roche Molecular Systems, Inc. | 2013-01-07 |
| GELFOAM (ABSORABLE GELATIN) POWDER, USP (N18286/S024) | Pfizer, Inc. | 2013-01-07 |
| ASCENDA INTRATHECAL CATHETER (P860004/S175) | Medtronic, Inc. | 2013-01-07 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S008) | Medtronic | 2013-01-07 |
| OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S039) | Biomet Manufacturing Corp | 2013-01-04 |
| DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S001) | Dexcom, Inc. | 2013-01-04 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S044) | W. L. Gore & Associates, Inc. | 2013-01-04 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S004) | Medtronic | 2013-01-04 |
| CAPSURE LEAD, CAPSURE SENSE BIPOLAR LEAD, VISTATRON CRYSTALINE LEAD, VISTRATRON EXCELLENCE PS+ LEAD (P830061/S084) | Medtronic Cardiac Rhythm Disease Management | 2013-01-03 |
| ATTAIN STARFIX LEAD (P060039/S041) | Medtronic, Inc. | 2013-01-03 |
| CONCERTO ICD, II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD,INSYNC MAXIMO ICD, II CRT-D,PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S315) | Medtronic Cardiac Rhythm Disease Management | 2013-01-03 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S095) | Boston Scientific Corp | 2013-01-03 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S011) | Medtronic | 2013-01-03 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S343) | Medtronic Cardiac Rhythm Disease Management | 2013-01-03 |
| ATTAIN BIPOLAR OTW LEAD (P010015/S186) | Medtronic, Inc. | 2013-01-03 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S093) | Cochlear Americas | 2013-01-03 |
| CAPSURE LEAD (P890003/S267) | Medtronic, Inc. | 2013-01-03 |
| ENTRUST ICD,INTRINSIC ICD,MARQUIS DR ICD,VR ICD,MAXIMO II ICD,VR ICD,PROTECTA ICD,XT ICD,SECURA ICD,VIRTUOSO ICD (P980016/S363) | Medtronic Cardiac Rhythm Disease Management | 2013-01-03 |
| Y ADAPTOR/EXTENDER KIT, SPRINT QUATTRO LEAD (P920015/S102) | Medtronic, Inc. | 2013-01-03 |
| CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD (P850089/S092) | Medtronic Cardiac Rhythm Disease Management | 2013-01-03 |
| SUREFIX LEAD (P930039/S080) | Medtronic, Inc. | 2013-01-03 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S147) | Boston Scientific Corp | 2013-01-03 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S393) | Medtronic Cardiac Rhythm Disease Management | 2013-01-03 |
| ATTAIN ABILITY LEAD (P080006/S049) | Medtronic, Inc. | 2013-01-03 |
| COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S028) | Roche Molecular Systems, Inc. | 2013-01-02 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S012) | Medtronic | 2013-01-02 |
| COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/BOBAS TAQMAN HCV TEST (P060030/S030) | Roche Molecular Systems, Inc. | 2013-01-02 |