| CAPSURE SP NOVUS LEADS, CAPSURE SP Z LEAD, CAPSURE Z NOVUSLEADS, IMPULSE II LEADS (P850089/S090) | Medtronic Cardiac Rhythm Disease Management | 2012-10-25 |
| CELSIUS DS CATHETER AND NAVI-STAR DS CATHETER (P010068/S030) | Biosense Webster, Inc. | 2012-10-24 |
| WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S025) | Boston Scientific Corporation | 2012-10-24 |
| WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S031) | Boston Scientific Scimed, Inc. | 2012-10-24 |
| PUNTUA, COGNIS, ENERGEN, AND INCEPTA CRT-D'S (P010012/S305) | Boston Scientific Corp | 2012-10-24 |
| WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S036) | Boston Scientific Corp | 2012-10-24 |
| CELSIUS CATHETERS (P950005/S040) | Biosense Webster, Inc. | 2012-10-24 |
| COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) (P010012/S306) | Boston Scientific Corp | 2012-10-24 |
| MODEL 3120 ZOOM LATTITUDE PROGRAMMING SYSTEM (P910077/S124) | Boston Scientific | 2012-10-24 |
| PUNCTUA, TELIGEN, ENERGEN, AND INCEPTA ICD'S (P960040/S273) | Boston Scientific | 2012-10-24 |
| TELIGEN IMPLANTABLE CARDIAC DEFIBRILLATORS (P960040/S274) | Boston Scientific | 2012-10-24 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S030) | Boston Scientific Corp | 2012-10-24 |
| VENTAK PRX AND VENTAK. MINI AUTOMATIC IMPLANTABLE CARDIOVERTER (P910077/S125) | Boston Scientific | 2012-10-24 |
| NAVI-STAR CATHETERS (P990025/S034) | Biosense Webster, Inc. | 2012-10-24 |
| CELSIUS THERMOCOOL CATHETERS (P030031/S048) | Biosense Webster, Inc. | 2012-10-24 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S055) | Boston Scientific Corp | 2012-10-24 |
| ULTRA AND ZETA RX CORONARY STENT SYSTEMS (P970020/S075) | Abbott Vascular, Inc. | 2012-10-23 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S017) | Boston Scientific Corporation | 2012-10-23 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) (P110019/S034) | Abbott Vascular | 2012-10-23 |
| XIENCE AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S101) | Abbott Vascular, Inc. | 2012-10-23 |
| XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S077) | Abbott Vascular, Inc. | 2012-10-23 |
| VISION AND ML8 CORONARY STENT SYSTEM (P020047/S051) | Abbott Vascular | 2012-10-23 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021) | Edwards Lifesciences, LLC | 2012-10-19 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S036) | Zoll Manufacturing Corporation | 2012-10-18 |
| TELIGEN, INCEPTA, ENERGEN, PUNCTUA IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR (P960040/S272) | Boston Scientific | 2012-10-17 |
| COGNIS, INCEPTA, ENERGEN, PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY HIGH EVERGY DEFIBRILLATOR (P010012/S304) | Boston Scientific Corp | 2012-10-17 |
| QUARTET IS4 LEAD MODELS 1458Q (P030054/S232) | ABBOTT MEDICAL | 2012-10-16 |
| ANGIOJET RHEOLOYTIC THROMBECTOMY SYSTEM (P980037/S040) | Boston Scientific Corp | 2012-10-16 |
| DURATA DF-4 LEAD MODELS 7120Q, 7121Q, 7170Q, 7171Q, 7172Q (P950022/S083) | ABBOTT MEDICAL | 2012-10-16 |
| CAPSUREFIX MRI LEAD, 5086MRI (P090013/S074) | Medtronic, Inc. | 2012-10-15 |
| ATTAIN STARFIX LEAD, 4195 (P060039/S037) | Medtronic, Inc. | 2012-10-15 |
| ANCHORING SLEEVE KIT, 5867AS, SELECTSECURE LEAD, 3830 (P030036/S048) | Medtronic Cardiac Rhythm Disease Management | 2012-10-15 |
| SPRINT QUATTRO LEAD, 6935, 6935M, 6944, 6947, 6947M (P920015/S096) | Medtronic, Inc. | 2012-10-15 |
| CAPSUREFIX NOVUS LEAD, 4076, 5076, VITATRON CRYSTALLINE LEADS, ICF09, ICQ09B (P930039/S074) | Medtronic, Inc. | 2012-10-15 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S293) | Medtronic, Inc. | 2012-10-15 |
| ATTAIN BIPOLAR OTW LEAD, 4194, LEFT VENTRICULAR PACING LEAD, 4193 (P010015/S179) | Medtronic, Inc. | 2012-10-15 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S016) | Boston Scientific Corporation | 2012-10-12 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S006) | Cordis US Corporation | 2012-10-12 |
| XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S033) | Abbott Vascular | 2012-10-11 |
| DURATA, DURATA DF4 (P950022/S084) | ABBOTT MEDICAL | 2012-10-10 |
| CURRENT, CURRENT ACCEL, CURRENT+, CURRENT RF, FORTIFY, EPIC/EPIC+, ATLAS/II/+ (P910023/S304) | ABBOTT MEDICAL | 2012-10-10 |
| EVIA PACEMAKER FAMILY (P950037/S112) | Biotronik, Inc. | 2012-10-10 |
| IDENTITY, INTEGRITY, AFFINITY, VERITY, VICTORY, ZEPHYR, SUSTAIN, ACCENT (P880086/S226) | ABBOTT MEDICAL | 2012-10-10 |
| LINOX LEAD FAMILY (P980023/S048) | Biotronik, Inc. | 2012-10-10 |
| REGENCY (P880006/S083) | St. Jude Medical, Inc. | 2012-10-10 |
| THINLINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS AND ACCESSORIES (P960004/S056) | Boston Scientific | 2012-10-10 |
| MICRONY (P970013/S052) | ABBOTT MEDICAL | 2012-10-10 |
| ISOFLEX P, ISOFLEX OPTIM, ISOFLEX S (P960030/S037) | ABBOTT MEDICAL | 2012-10-10 |
| LUMAX ICD FAMILY (P050023/S055) | Biotronik, Inc. | 2012-10-10 |
| ARCTIC FRONT CARDIAC CRYOABLATION CATHETERS (P100010/S019) | Medtronic Cryocath, LP | 2012-10-10 |
| QUICKSITE, QUICKFLEX, QUICKFLEX MICRO, QUARTET, PROMOTE, PROMOTE+, PROMOTE RF, PROMOTE ACCEL, PROMOTE Q,PROMOTE QUADRA (P030054/S233) | ABBOTT MEDICAL | 2012-10-10 |
| COROX LEAD FAMILY (P070008/S034) | Biotronik, Inc. | 2012-10-10 |
| ANTHEM, FRONTIER II (P030035/S104) | ABBOTT MEDICAL | 2012-10-10 |
| TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE (P960013/S074) | ABBOTT MEDICAL | 2012-10-10 |
| RX HERCULINK ELITE RENAL STENT SYSTEM (P110001/S009) | Abbott Vascular | 2012-10-09 |
| ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S046) | Cook, Inc. | 2012-10-09 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV) (P060038/S012) | Corcym Canada Corp | 2012-10-09 |
| ENDOTAK LEAD SYSTEM FAMILY (P910073/S105) | Boston Scientific | 2012-10-05 |
| THINLINE/FINELINE LEADS FAMILIES (P960004/S054) | Boston Scientific | 2012-10-05 |
| VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY (P830060/S072) | Boston Scientific | 2012-10-05 |
| VENTAK P /P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILIES (P930035/S022) | Boston Scientific | 2012-10-05 |
| CONTAK CD, EASYTRAK, LIVIAN, COGNIS, AND ACUITY SPIRAL FAMILIES (P010012/S295) | Boston Scientific Corp | 2012-10-05 |
| CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) (P030005/S087) | Guidant Corp. | 2012-10-05 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P010012/S303) | Boston Scientific Corp | 2012-10-05 |
| XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S018) | Abbott Vascular | 2012-10-05 |
| VENTAK AV AND PRIZM DR/VR, VITALITY, CONFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVERTER DEBRILLAOR (AICD) SYSTEM (P960040/S265) | Boston Scientific | 2012-10-05 |
| VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) FAMILIES (P910077/S122) | Boston Scientific | 2012-10-05 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S271) | Boston Scientific | 2012-10-05 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S024) | ABBOTT MEDICAL | 2012-10-05 |
| OVATION ABDOMINAL STENT GRAFT SYSTEM (P120006) | Endologix, LLC | 2012-10-05 |
| CAPSUREFIX MRI SURESCAN LEAD, 5086MRI (P090013/S073) | Medtronic, Inc. | 2012-10-04 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S092) | Edwards Lifesciences, LLC | 2012-10-04 |
| 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 |
| 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 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S178) | Medtronic, Inc. | 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 |