| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S035) | Edwards Lifesciences, LLC | 2012-12-10 |
| VENTAK PRX AND VENTAK MINI ICD FANILIES (P910077/S129) | Boston Scientific | 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 |
| VENTAK ICD FAMILIES (P890061/S022) | Boston Scientific | 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 |
| 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 |
| 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 |
| 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 |
| CONTAK RENEWAL TR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FAMILY (P030005/S093) | Guidant Corp. | 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 |
| 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 |
| ADVISA DR IPG (P980035/S299) | Medtronic, Inc. | 2012-12-04 |
| STRATOS LV & STRATOS LV-T (P070008/S032) | Biotronik, Inc. | 2012-12-03 |
| PHILOS, CYLOS, EVIA, ESTELLA, EFFECTA FAMILY IMPLANTABLE PULSE GENERATORS (P950037/S107) | Biotronik, Inc. | 2012-12-03 |
| ON-X PROSTHETIC HEART VALVE (P000037/S031) | On-X Life Technologies, Inc. | 2012-12-01 |
| 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 |
| 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 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S060) | Boston Scientific Corp | 2012-11-29 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S034) | Boston Scientific Corp | 2012-11-29 |
| TELIGEN, INCEPT, ENERGEN AND PUNCTUA ICDS (P960040/S280) | Boston Scientific | 2012-11-29 |
| COGNIS, INCEPTA, ENERGEN, PUNCTUA CRTS (P010012/S313) | Boston Scientific Corp | 2012-11-29 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S051) | Thoratec Laboratories Corp. | 2012-11-29 |
| CAPSUREFIX NOVUS LEAD (P930039/S077) | Medtronic, Inc. | 2012-11-28 |
| CAPSUREFIX MRI LEAD (P090013/S079) | Medtronic, Inc. | 2012-11-28 |
| CAPSURE EPI PACING LEADS (P950024/S044) | Medtronic, Inc. | 2012-11-27 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S011) | Boston Scientific Corp | 2012-11-27 |
| CAPSURE EPI PACING LEADS (P950024/S040) | Medtronic, Inc. | 2012-11-27 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S029) | W. L. Gore & Associates, Inc. | 2012-11-26 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL VALVES (P860057/S095) | Edwards Lifesciences, LLC | 2012-11-26 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S061) | Boston Scientific Corp | 2012-11-23 |
| EXPRESS 2 CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P020009/S096) | Boston Scientific Scimed, Inc. | 2012-11-23 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S095) | Boston Scientific Scimed, Inc. | 2012-11-23 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S062) | Boston Scientific Corp | 2012-11-23 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S033) | Boston Scientific Corp | 2012-11-23 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S036) | Boston Scientific Corp | 2012-11-23 |
| VERIFLEX CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P040016/S101) | Boston Scientific Scimed, Inc. | 2012-11-23 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S036) | Boston Scientific Corp | 2012-11-23 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S059) | Boston Scientific Corp | 2012-11-23 |
| IOP (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S058) | Boston Scientific Corp | 2012-11-23 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S037) | Boston Scientific Corp | 2012-11-23 |
| VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM (P040016/S100) | Boston Scientific Scimed, Inc. | 2012-11-23 |
| BARD LIFESTENT VASCULAR STENT SYSTEMS (P070014/S035) | Bard Peripheral Vascular, Inc. | 2012-11-21 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S032) | Boston Scientific Corp | 2012-11-20 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S031) | Abbott Vascular | 2012-11-20 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S074) | W. L. Gore & Associates, Inc. | 2012-11-20 |
| CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S094) | Edwards Lifesciences, LLC | 2012-11-20 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S075) | W. L. Gore & Associates, Inc. | 2012-11-20 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S072) | Medtronic, Inc. | 2012-11-20 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV) (P060038/S015) | Corcym Canada Corp | 2012-11-20 |
| OPEN PIVOT HEART VALVE (P990046/S030) | Medtronic Ats Medical, Inc. | 2012-11-20 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S022) | Medtronic Vascular | 2012-11-20 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S057) | Boston Scientific Corp | 2012-11-20 |
| ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS (P100010/S021) | Medtronic Cryocath, LP | 2012-11-20 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (P010030/S038) | Zoll Manufacturing Corporation | 2012-11-20 |
| STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION (P990071/S020) | Biosense Webster, Inc. | 2012-11-20 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047) | Medtronic | 2012-11-20 |
| SELECTSECURE 4 FRENCH LEAD, 3830 (P030036/S050) | Medtronic Cardiac Rhythm Disease Management | 2012-11-19 |
| ATTAIN ABILITTY LV LEAD, 4196, ATTAIN ABILITY PLUS LV LEAD, 4296, ATTAIN ABILITY STRAIGHT LV LEAD, 4296 (P080006/S046) | Medtronic, Inc. | 2012-11-19 |
| CAPSURE FIX MRI LEAD, 5086MRI (P090013/S078) | Medtronic, Inc. | 2012-11-19 |
| CAPSURE SENSE LEAD, 4073, CAPSURE SENSE UNIPOLAR LEAD, CAPSURE BIPOLAR LEAD, VITATRON CRYSTALINE LEAD, VITATRON CRYSTALI (P830061/S081) | Medtronic Cardiac Rhythm Disease Management | 2012-11-19 |
| CAPSURE FIX NOVUS LEAD, 4076 AND VITATRON CRYSTALLINE LEADS, ICQ09B (P930039/S076) | Medtronic, Inc. | 2012-11-19 |
| ENTRUSTICD,INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD (P980016/S387) | Medtronic Cardiac Rhythm Disease Management | 2012-11-16 |
| OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYTEM (P110043/S003) | Abbott Vascular-Cardiac Therapies | 2012-11-16 |
| REVO MRI IPG (P090013/S077) | Medtronic, Inc. | 2012-11-16 |
| PRODIGY IPG (P890003/S264) | Medtronic, Inc. | 2012-11-16 |
| CONCERTO ICD,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,MAXIMO II CRT-D (P010031/S339) | Medtronic Cardiac Rhythm Disease Management | 2012-11-16 |
| ADAPTA,ADAPTA L,ADAPTA S,SENSIA L,SENSIA,VERSA IPG,ADVISA DR IPG,ENRHYTHM IPG,RELIA,SIGMA DR IPG (P980035/S297) | Medtronic, Inc. | 2012-11-16 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S005) | Abbott Vascular, Inc. | 2012-11-14 |
| INVIVE CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (P030005/S085) | Guidant Corp. | 2012-11-14 |
| RELIANCE IS-4 DEFIBRILLATION LEAD (P910073/S111) | Boston Scientific | 2012-11-14 |
| INCEPTA, ENERGEN, PUNCTUA, COGNIS, LIVIAN (P010012/S296) | Boston Scientific Corp | 2012-11-14 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022) | Cook Ireland, Ltd. | 2012-11-14 |
| LATITUDE/PROGRAMMER/RECORDER/MONITOR (P910077/S128) | Boston Scientific | 2012-11-14 |
| INCEPTA, ENERGEN, PUNCTUA, TELIGEN, CONFIENT (P960040/S266) | Boston Scientific | 2012-11-14 |
| LEGOO (P110003/S003) | Genzyme Corp. | 2012-11-13 |
| LEGOO ENDOVASCULAR OCCLUSION GEL (P110003/S002) | Genzyme Corp. | 2012-11-13 |
| BARD ABLATION SYSTEM (P000020/S016) | Boston Scientific Corp | 2012-11-13 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S015) | Edwards Lifesciences, LLC | 2012-11-13 |
| CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S093) | Edwards Lifesciences, LLC | 2012-11-13 |
| SELUTE LEAD FAMILY (P950001/S024) | Boston Scientific | 2012-11-09 |
| CONTAK CD, LIVIAN, COGNIS FAMILIES OF CRT-DS; EASYTRAK, ACUITY SPRIAL FAMILIES OF LV PACING LEADS (P010012/S308) | Boston Scientific Corp | 2012-11-09 |