| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD (P980016/S455) | Medtronic Cardiac Rhythm Disease Management | 2014-03-05 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORNARY STENT SYSTEM (P110013/S034) | Medtronic Vascular | 2014-03-04 |
| BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S426) | Medtronic Cardiac Rhythm Disease Management | 2014-03-04 |
| CURRENT , ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S330) | ABBOTT MEDICAL | 2014-03-04 |
| PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S261) | ABBOTT MEDICAL | 2014-03-04 |
| INTEGRITY CORONARY STENT STYSTEMS (P030009/S074) | Medtronic, Ireland | 2014-03-04 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD (P980016/S464) | Medtronic Cardiac Rhythm Disease Management | 2014-03-04 |
| UNIFY, UNIFY ASSURA, UNIFY QUADRA AND QUADRA ASSURA CRT-D'S (P030054/S260) | ABBOTT MEDICAL | 2014-03-04 |
| ANTHEM FAMILY OF CRT-P DEVICES (P030035/S117) | ABBOTT MEDICAL | 2014-03-04 |
| IDENTITY, SUSTAINXL, VERITY VICTORY ZEPHYR, ACCENT FAMILIES OF PACEMAKER DEVICE (P880086/S239) | ABBOTT MEDICAL | 2014-03-04 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S088) | Medtronic, Inc. | 2014-03-04 |
| FORTIFY, FORTIFY ASSURA AND ELLIPSE ICDS (P910023/S329) | ABBOTT MEDICAL | 2014-03-04 |
| COMPLETE SE VASCULAR STENT SYSTEM (P110040/S004) | Medtronic Vascular | 2014-02-28 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM ; XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S053) | Abbott Vascular | 2014-02-28 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEM (P110010/S072) | Boston Scientific Corp | 2014-02-27 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S462) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P) INVIVE AND INTUA MODELS (P030005/S105) | Guidant Corp. | 2014-02-27 |
| REVO MRI IPG (P090013/S124) | Medtronic, Inc. | 2014-02-27 |
| MYCARELINK PATIENT MONITOR (P890003/S299) | Medtronic, Inc. | 2014-02-27 |
| ENTRUST ICD,INTRINSIC 30 ICD, INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, KAPPA DR(KAPPA 700/600)IPG, KAP (P980016/S454) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S233) | Medtronic, Inc. | 2014-02-27 |
| FORMIO, VITALIO, ADVANTIO, INGENIO-- PACEMAKER (N970003/S158) | Boston Scientific Corp | 2014-02-27 |
| PARADYM VR 8750,PARADYM DR8750,PARADYM RF CRT-D9750 (P980049/S092) | MicroPort CRM USA, Inc. | 2014-02-27 |
| SELECTSECURE LEAD FAMILY (P030036/S070) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| PARADYM CRT-D 8750; PARADYM RF CRT-D9750 (P060027/S058) | MicroPort CRM USA, Inc. | 2014-02-27 |
| MYCARELINK MONITOR, (P890003/S295) | Medtronic, Inc. | 2014-02-27 |
| REVO MRI IPG (P090013/S130) | Medtronic, Inc. | 2014-02-27 |
| INSYNC II PROTECT ICD, INSYNC III MARQUIS ICD,INSYNC MARQUIS ICD,INSYNC MAXIMO ICD,BRAVA CRT-D,CONCERTO ICD,CONCERTO II (P010031/S416) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD (P830061/S107) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| SPRINT QUATTRO LEAD FAMILY (P920015/S129) | Medtronic, Inc. | 2014-02-27 |
| EVERA S DR/VR, EVERA XT DR/VR ICD'S; MAXIMO II ICD; PRTOECTA/PROTECTA XT ICD'S; SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S460) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| EPICARDIAL PATCH LEAD FAMILY (P900061/S127) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| ADAPTA, VERA, SENSIA IPG'S; ADVISA DR/DR MRI IPG'S (P980035/S365) | Medtronic, Inc. | 2014-02-27 |
| INSYNC; INSYNC III; ATTAIN LEAD; ATTAIN OTW LEAD (P010015/S217) | Medtronic, Inc. | 2014-02-27 |
| BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE (P010031/S413) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S087) | MicroPort CRM USA, Inc. | 2014-02-27 |
| PRMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (CMS) (P110010/S074) | Boston Scientific Corp | 2014-02-27 |
| ADAPTA,VERSA ,SENSIA IPG, ADVISA DR IPG.ADVISA DR MRI IPG,ENPULSE E1 IPG,ENPULSE E2 IPG, ENRHYTHM IPG,KAPPA D(KAPPA 700) (P980035/S360) | Medtronic, Inc. | 2014-02-27 |
| EVERA S DR/S VR ICD'S, EVERA XT DR/VR ICD'S, MAXIMO II ICD, PROTECTA/PROTECTA XT ICD'S; SECURA ICD, VIRTUOSO II DR/VR IC (P980016/S461) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PHATINUM CHROMIUM CORONARY STENT SYSTEM- (MES) (P110010/S073) | Boston Scientific Corp | 2014-02-27 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S069) | Boston Scientific Corp | 2014-02-27 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S424) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (P980049/S091) | MicroPort CRM USA, Inc. | 2014-02-27 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D9750 (P060027/S059) | MicroPort CRM USA, Inc. | 2014-02-27 |
| CAPSUREFIX LEAD; CAPSUREFIX NOVIS LEAD, SUREFIX LEAD (P930039/S104) | Medtronic, Inc. | 2014-02-27 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S071) | Boston Scientific Corp | 2014-02-27 |
| ADAPTA, VERSA, SENSIA IPG'S; ADVISA DR/DR MRI IPG'S (P980035/S366) | Medtronic, Inc. | 2014-02-27 |
| BRAVA CRT-D, CONCERTA II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA/PROTECTA XT CRT-D S/VIVA XT CRT-D (P010031/S422) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| CAPSURE LEAD (P890003/S302) | Medtronic, Inc. | 2014-02-27 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D VIVA S CRT-D, VIVA XT CRT (P010031/S423) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD (P850089/S106) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD, VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE (P980016/S451) | Medtronic Cardiac Rhythm Disease Management | 2014-02-27 |
| CONSULTA CRT-P,SYNCRA CRT-P (P010015/S229) | Medtronic, Inc. | 2014-02-27 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S058) | Medtronic, Inc. | 2014-02-27 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S070) | Boston Scientific Corp | 2014-02-27 |
| REVO MRI IPG (P090013/S131) | Medtronic, Inc. | 2014-02-27 |
| CAPSUREFIX MRI LEAD (P090013/S129) | Medtronic, Inc. | 2014-02-27 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S057) | ABBOTT MEDICAL | 2014-02-26 |
| SENSOLOG/DIALOG/ REGENCY FAMILY OF PACEMAKERS (P880006/S087) | St. Jude Medical, Inc. | 2014-02-26 |
| AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S237) | ABBOTT MEDICAL | 2014-02-26 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S033) | Medtronic Vascular | 2014-02-26 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY PF CRT-DS (P030054/S254) | ABBOTT MEDICAL | 2014-02-26 |
| FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-PS (P030035/S115) | ABBOTT MEDICAL | 2014-02-26 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S323) | ABBOTT MEDICAL | 2014-02-26 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S038) | Medtronic Vascular | 2014-02-26 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S016) | Medtronic Vascular | 2014-02-26 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S036) | Medtronic | 2014-02-21 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S087) | Medtronic, Inc. | 2014-02-21 |
| OPTISURE (P950022/S085) | ABBOTT MEDICAL | 2014-02-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S091) | W. L. Gore & Associates, Inc. | 2014-02-21 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S048) | Zoll Manufacturing Corporation | 2014-02-21 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S053) | Corcym S.r.l. | 2014-02-20 |
| CAPSURE SENSE LEAD (P830061/S086) | Medtronic Cardiac Rhythm Disease Management | 2014-02-18 |
| ATTAIN ABILITY LEAD (P080006/S066) | Medtronic, Inc. | 2014-02-18 |
| REVO MRI IPG (P090013/S128) | Medtronic, Inc. | 2014-02-18 |
| CURRENT, ELLIPSE, FORTIFY, FORTIFYASSURA FAMILIES OF ICD DEVICES (P910023/S327) | ABBOTT MEDICAL | 2014-02-18 |
| BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S421) | Medtronic Cardiac Rhythm Disease Management | 2014-02-18 |
| PROMOTE, QUADRA ASSURA, UNITY, UNITY ASSURA, UNIFY QUADRA FAMILIES CRT-D DEVICES (P030054/S258) | ABBOTT MEDICAL | 2014-02-18 |
| ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG (P980035/S364) | Medtronic, Inc. | 2014-02-18 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT (P980016/S459) | Medtronic Cardiac Rhythm Disease Management | 2014-02-18 |
| CONSULTA CRT-P,SYNCRA CRT-P (P010015/S232) | Medtronic, Inc. | 2014-02-18 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S457) | Medtronic Cardiac Rhythm Disease Management | 2014-02-18 |
| BRAVA CRT-D; VIVA S CRT-D; VIVA XT CRT-D (P010031/S419) | Medtronic Cardiac Rhythm Disease Management | 2014-02-18 |
| REVO MRI IPG (P090013/S112) | Medtronic, Inc. | 2014-02-14 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, DR MRI IPG, ENPULSE EL IPG, E2 IPG, ENRHYTHM IPG, KAPPA D IPG (P980035/S343) | Medtronic, Inc. | 2014-02-14 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S215) | Medtronic, Inc. | 2014-02-14 |
| ENTRUST ICD, INTRINSIC 30ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, VR ICD, EVERA S DR ICD, S VR ICD,XT VR ICD, MAXIMO (P980016/S436) | Medtronic Cardiac Rhythm Disease Management | 2014-02-14 |
| INSYNC II PROTECT ICD, IIIMARQUIS ICD, MARQUIS ICD, MAXIMO ICD, BRAVA CRT-D, CONCERTO ICD, II CRT-D, CONSULTA ICD, MAXIM (P010031/S397) | Medtronic Cardiac Rhythm Disease Management | 2014-02-14 |
| MYCARELINK PATIENT MONITOR, DEVICE DATA MANAGEMENT APPLICATION, APPLICATION SOFTWARE (P890003/S285) | Medtronic, Inc. | 2014-02-14 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S026) | Medtronic | 2014-02-14 |
| TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S101) | Boston Scientific Corp | 2014-02-13 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS- ELUTING STENT SYSTEM (P110010/S065) | Boston Scientific Corp | 2014-02-13 |
| BLAZER II XPCARDIAC ABLATION CATHETER AND CABLE (P020025/S053) | Boston Scientific | 2014-02-13 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P110010/S058) | Boston Scientific Corp | 2014-02-13 |
| EXPRESS 2 MONORAIL AND OVER THE WIRE (P020009/S115) | Boston Scientific Scimed, Inc. | 2014-02-13 |
| ROTABLATOR ROTATIONAL ANGIOPASTY SYSTEM GUIDEWIRE (P900056/S131) | Boston Scientific Corp | 2014-02-13 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S065) | Boston Scientific Corp | 2014-02-13 |
| HEART WARE VENTRICULAR ASSIST SYSTEM (P100047/S033) | Medtronic | 2014-02-13 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S121) | Boston Scientific Scimed, Inc. | 2014-02-13 |
| FLEXTOME CUTTING BALLOON DILATATION DEVICE (P950020/S067) | Boston Scientific Corp | 2014-02-13 |