| VIRTUOSO DR,VIRTUOSO VR,SECURA DR,MAXIMO II DR,VIRTUOSO II DR,SECURA VR,MAXIMO II VR,VIRTUOSO II VR,PROTECTA XT DR,PROTE (P980016/S431) | Medtronic Cardiac Rhythm Disease Management | 2013-10-07 |
| CHILLI COOLED ABLATION SYSTEM (P980003/S041) | Boston Scientific Corp | 2013-10-07 |
| MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS (P890003/S283) | Medtronic, Inc. | 2013-10-07 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S060) | Boston Scientific Corp | 2013-10-07 |
| CONSULTA CRT D,MAXIMO II CRT-D,CONCERTO II CRT-D,CONCERTO CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA XT CRT-D,VIVA S,BR (P010031/S392) | Medtronic Cardiac Rhythm Disease Management | 2013-10-07 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S387) | Medtronic Cardiac Rhythm Disease Management | 2013-10-04 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S032) | W. L. Gore & Associates, Inc. | 2013-10-04 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S426) | Medtronic Cardiac Rhythm Disease Management | 2013-10-04 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S055) | W. L. Gore & Associates, Inc. | 2013-10-04 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S054) | Abbott Vascular | 2013-10-04 |
| ARTIC FRONT CRYOABLATION CATHETER,ARTIC FRONT ADVANCE CRYOABLATION CATHETER (P100010/S026) | Medtronic Cryocath, LP | 2013-10-03 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S044) | Zoll Manufacturing Corporation | 2013-10-03 |
| CVX-300 AND CVX-300-P EXCIMER LASER SYSTEMS (P910001/S067) | Spectranetics Corp. | 2013-10-02 |
| BRAVA CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S399) | Medtronic Cardiac Rhythm Disease Management | 2013-10-02 |
| REPLY SR,REPLY DR,ESPRIT SR,ESPRIT DR (P950029/S084) | MicroPort CRM USA, Inc. | 2013-10-02 |
| 3F AORTIC BIOPROSTHESIS, MODEL 1000 (P060025/S012) | Medtronic, Inc. | 2013-10-02 |
| PARADYM VR 8750,PARADYM DR8750,ISOLINE 2CT-ISOLINE 2CR (P980049/S087) | MicroPort CRM USA, Inc. | 2013-10-02 |
| STELID II BTF/BJF - STELIX II BRF (P020030/S010) | MicroPort CRM USA, Inc. | 2013-10-02 |
| ACCENT PACEMAKERS (P880086/S235) | ABBOTT MEDICAL | 2013-10-02 |
| TENDRIL AND OPTISENSE FAMILY OF LEADS (P960013/S076) | ABBOTT MEDICAL | 2013-10-02 |
| ISOFLEX FAMILY OF LEADS (1944,1948) (P960030/S038) | ABBOTT MEDICAL | 2013-10-02 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S438) | Medtronic Cardiac Rhythm Disease Management | 2013-10-02 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D9750,SITUS OTW UW28D (P060027/S055) | MicroPort CRM USA, Inc. | 2013-10-02 |
| ANTHEM CRT-PS (P030035/S113) | ABBOTT MEDICAL | 2013-10-02 |
| CAMERON HEALTH SUBCUTANCEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S014) | Boston Scientific Corporation | 2013-09-27 |
| INSYNC II PROTECT, INSYNC III MARQUIS,INSYNC MARQUIS, INSYNC MAXIMO ICDS (P010031/S386) | Medtronic Cardiac Rhythm Disease Management | 2013-09-27 |
| WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S036) | Boston Scientific Corporation | 2013-09-27 |
| EPIC VASCULAR SELF EXPANDING STENT SYSTEM (P110035/S019) | Boston Scientific Corp | 2013-09-27 |
| ADAPTA,VERSA,SENSIA,ADVISA DR,ADVISA DR MRI,ENPULSE E1,ENPULSE E2,ENRHYTHM,KAPPA D(KAPPA 700),KAPPA D (KAPPA 900) IPG, K (P980035/S338) | Medtronic, Inc. | 2013-09-27 |
| ION PACLITAEL-ELUTING CORONARY STENT SYSTEM (P100023/S077) | Boston Scientific Corp | 2013-09-27 |
| THERAPY ABLATION CATHETERS (P040014/S020) | Irvine Biomedical, Inc. | 2013-09-27 |
| ROTABLATOR ROTALIONAL ATHERECTOMY SYSTEM (P900056/S126) | Boston Scientific Corp | 2013-09-27 |
| FREEZOR CARDIAC ABLATION CATHETER (P020045/S050) | Medtronic Cryocath, LP | 2013-09-27 |
| THERAPY COOL PATH DUO AND SAFIRE BLU DUO ABLATION CATHETERS (P110016/S009) | ABBOTT MEDICAL | 2013-09-27 |
| FLEXTOME CUTTINGG BALLOON DILATATION DEVICE (P950020/S064) | Boston Scientific Corp | 2013-09-27 |
| THERAPY DUAL 8 ABLATION CATHETERS (P040042/S025) | Irvine Biomedical,Inc.(Ibi) | 2013-09-27 |
| BLAZER,BLAZER II HTD, AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS (P920047/S059) | Boston Scientific Corp | 2013-09-27 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S048) | Boston Scientific Corp | 2013-09-27 |
| CONSULTA CRT-P,SYNCRA CRT-P (P010015/S208) | Medtronic, Inc. | 2013-09-27 |
| ENTRUST,INTRINSIC 30,INTRINSIC,MARQUIS DR,MARQUIS VR,MAXIMO DR,MAXIMO VR ICDS (P980016/S425) | Medtronic Cardiac Rhythm Disease Management | 2013-09-27 |
| THERAPY COOL PATH ABLATION CATHETERS (P060019/S024) | Irvine Biomedical, Inc. | 2013-09-27 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S106) | Boston Scientific Corp | 2013-09-27 |
| REVO MRI IPG (P090013/S107) | Medtronic, Inc. | 2013-09-27 |
| PROMUS ELEMENT PLUS EVEROLIMUS ELUTING PLATINUM STENT SYSTEM (P110010/S060) | Boston Scientific Corp | 2013-09-27 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S040) | Boston Scientific Corp | 2013-09-27 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S027) | Boston Scientific Corporation | 2013-09-27 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S017) | Boston Scientific Corp | 2013-09-27 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S115) | Boston Scientific Scimed, Inc. | 2013-09-27 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S054) | Boston Scientific Corp | 2013-09-27 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S109) | Boston Scientific Scimed, Inc. | 2013-09-27 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM AND ACCESSORIES, AND BLAZER II XP, BLAZER PRIME XP ABLATION CATHETERS (P020025/S043) | Boston Scientific | 2013-09-27 |
| WALLSTENT LLIAC ENDOPROSTHESIS (P940019/S040) | Boston Scientific Scimed, Inc. | 2013-09-27 |
| WALLSTENT TIPS ENDOPROSTHESIS (P930031/S047) | Boston Scientific Corp | 2013-09-27 |
| MYCARELINK PATIENT MONITOR (P890003/S280) | Medtronic, Inc. | 2013-09-27 |
| CYLOS , PHILOS, PHILOS II, EVIA, ENTOVIS, EURO EFFECTA, ESTELLA FAMILY (P950037/S128) | Biotronik, Inc. | 2013-09-26 |
| LUMAX 300/340; 500/540; 540 VR-T DX; 600/640;700/740 FAMILY, IFORIA 7/5 FAMILY; ILESTO 7/5/FAMILY (P050023/S069) | Biotronik, Inc. | 2013-09-26 |
| LUMAS FAMILY (P000009/S055) | Biotronik, Inc. | 2013-09-26 |
| TELIGEN, INCEPTA,ENERGEN AND PUNCTUA ICDS (P960040/S305) | Boston Scientific | 2013-09-26 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S040) | Bard Peripheral Vascular, Inc. | 2013-09-26 |
| STRATOS FAMILY, EVIA FAMILY, ENTOVIS FAMILY (P070008/S047) | Biotronik, Inc. | 2013-09-26 |
| PARADYM VR 8750,PARADYM DR8750,PARADYM RF VR 9750,PARADYM RF DR 9750 (P980049/S086) | MicroPort CRM USA, Inc. | 2013-09-26 |
| ENTOVIS HF (-T),EVIA HF(-T) (P070008/S046) | Biotronik, Inc. | 2013-09-26 |
| ECURO,EFFECTA,ESTELLA,EVIA,ENTOVIS (P950037/S127) | Biotronik, Inc. | 2013-09-26 |
| ADAPTA,VERSA,SENSIA IPG, RELIA IPG (P980035/S344) | Medtronic, Inc. | 2013-09-26 |
| REPLY SR,REPLY DR,ESPRIT SR,ESPRIT DR (P950029/S083) | MicroPort CRM USA, Inc. | 2013-09-26 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D9750 (P060027/S054) | MicroPort CRM USA, Inc. | 2013-09-26 |
| PROTECTA XT CRT-D, PROTECTA CRT-D, CONSULTA CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-D (P010031/S344) | Medtronic Cardiac Rhythm Disease Management | 2013-09-25 |
| SELUTE LEAD SYSTEM (P950001/S026) | Boston Scientific | 2013-09-25 |
| DELTA/ VISTA (P840068/S053) | Boston Scientific | 2013-09-25 |
| HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S028) | ABBOTT MEDICAL | 2013-09-25 |
| VENTAK P AICD SYSTEMS (P890061/S023) | Boston Scientific | 2013-09-25 |
| ENDOTAK LEAD SYSTEM (P910073/S121) | Boston Scientific | 2013-09-25 |
| VENTAK AV AND VENTAK PRIZM DR/VR,VITALITY,CONFIENT,TELIGEN,PUNCTUA ICD,ENERGEN ICD,AND INCEPTA ICD AICD SYSTEMS (P960040/S304) | Boston Scientific | 2013-09-25 |
| PROTECTA XT ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II ICD, MAXIMO II ICD (P980016/S394) | Medtronic Cardiac Rhythm Disease Management | 2013-09-25 |
| VIGOR DR/SR,DISCOVERY,MERIDIAN (P940031/S075) | Boston Scientific | 2013-09-25 |
| VENTAK P2 AICD SYSTEMS (P930035/S025) | Boston Scientific | 2013-09-25 |
| PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE DEVICE, PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM (P960043/S084) | Abbott Vascular, Inc. | 2013-09-25 |
| VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS (P830060/S076) | Boston Scientific | 2013-09-25 |
| COSMOS (P830026/S082) | Boston Scientific | 2013-09-25 |
| PULSAR, PULSAR MAX, INSIGNIA, ALTRUA, ADVANTIO, INGENIO (N970003/S155) | Boston Scientific Corp | 2013-09-25 |
| SWEET TIP RX,SWEET PICOTIP RX, AND FLEXTEND LEAD SYSTEMS (P960006/S040) | Boston Scientific | 2013-09-25 |
| THINLINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS (P960004/S063) | Boston Scientific | 2013-09-25 |
| CONTAK RENEWAL TR AND INVIVE CRT-P SYSTEMS (P030005/S102) | Guidant Corp. | 2013-09-25 |
| ACUITY STEERABLE LEAD SYSTEM (P050046/S021) | Guidant Corp. | 2013-09-25 |
| CONTAK CD, EASYTRAK, LIVIAN, COGNIS, AND ACUITY SPIRAL, ENERGEN CRT-D, PUNCTUA CRT-D, INCEPTA CRT-D (P010012/S340) | Boston Scientific Corp | 2013-09-25 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S015) | Boston Scientific Corporation | 2013-09-25 |
| VENTAK PRX AND VENTAK MINI AICD (P910077/S137) | Boston Scientific | 2013-09-25 |
| HANCOCK II BIOPROSTHETIC HEART VALVE (P980043/S042) | Medtronic, Inc. | 2013-09-24 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S038) | Medtronic Heart Valves | 2013-09-24 |
| HANCOCK PORCINE BIOPROSTHESIS (P870078/S021) | Medtronic, Inc. | 2013-09-24 |
| TRIVASCULAR, INC OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S006) | Endologix, LLC | 2013-09-24 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S050) | Medtronic, Inc. | 2013-09-24 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S042) | Medtronic, Inc. | 2013-09-24 |
| ROTABLATOR ROTATIONAL ATHRECTOMY SYSTEM (P900056/S123) | Boston Scientific Corp | 2013-09-24 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CONONARY STENT SYSTEM (P070015/S111) | Abbott Vascular, Inc. | 2013-09-23 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S044) | Edwards Lifesciences, LLC | 2013-09-23 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S112) | Edwards Lifesciences, LLC | 2013-09-23 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S039) | Edwards Lifesciences, LLC | 2013-09-23 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LOW (P870077/S055) | Edwards Lifesciences, LLC | 2013-09-23 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S042) | Edwards Lifesciences, LLC | 2013-09-23 |