| MAXIMO II,PROTECTA,PROTECTA XT,SECURA AND VIRTUOSO II DR/VR ICDS (P980016/S510) | Medtronic Cardiac Rhythm Disease Management | 2014-12-12 |
| TRIFECTA VALVE (P100029/S018) | ABBOTT MEDICAL | 2014-12-12 |
| CONCERTO II,CONSULTA,MAXIMO II,PROTECTA AND PROTECTA XT CRT-DS (P010031/S474) | Medtronic Cardiac Rhythm Disease Management | 2014-12-12 |
| ELLIPSE/FORTIFY ASSURA FAMILY OS ICD'S (P910023/S346) | ABBOTT MEDICAL | 2014-12-11 |
| FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-P'S (P030035/S127) | ABBOTT MEDICAL | 2014-12-11 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHR/ACCENT FAMILY OF PACEMAKERS (P880086/S249) | ABBOTT MEDICAL | 2014-12-11 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S052) | Medtronic | 2014-12-11 |
| QUADRA ASSURA / UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S276) | ABBOTT MEDICAL | 2014-12-11 |
| FINELINE II STEROID-ELUTING PACING LEADS (P960004/S067) | Boston Scientific | 2014-12-11 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S093) | Medtronic, Inc. | 2014-12-10 |
| ATTAIN PERFORMA MODEL 4398 AND 4598 LEFT VENTRICULAR LEADS (P080006/S073) | Medtronic, Inc. | 2014-12-10 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S013) | Medtronic Vascular, Inc. | 2014-12-10 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S047) | Medtronic Vascular | 2014-12-10 |
| MEDTRONIC COREVALVE (R) SYSTEM (P130021/S008) | Medtronic, Inc. | 2014-12-10 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S102) | Boston Scientific Corp | 2014-12-08 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S062) | Boston Scientific Corp | 2014-12-08 |
| BLAZER II XP CARDIAC ABLATION CATHETER (P020025/S061) | Boston Scientific | 2014-12-08 |
| CELSIUS ELECTROPHYSIOLOGY CATHETER (P950005/S055) | Biosense Webster, Inc. | 2014-12-08 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S089) | Boston Scientific Corp | 2014-12-08 |
| NAVISTAR ELECTROPHYSIOLOGY CATHETER (P990025/S043) | Biosense Webster, Inc. | 2014-12-08 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S139) | Boston Scientific Corp | 2014-12-08 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S053) | Boston Scientific Corp | 2014-12-08 |
| NAVISTAR THERMOCOOL ELECTROPHYSIOLOGY CATHETER, CELSIUS THERMOCOOL ELECTROPHYSIOLOGY CATHETER (P030031/S064) | Biosense Webster, Inc. | 2014-12-08 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM (P020009/S125) | Boston Scientific Scimed, Inc. | 2014-12-08 |
| BLAZER II CARDIAC ABLATION CATHETER (P920047/S073) | Boston Scientific Corp | 2014-12-08 |
| NAVISTAR DS ELECTROPHYSIOLOGY CATHETER (P010068/S044) | Biosense Webster, Inc. | 2014-12-08 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S131) | Boston Scientific Scimed, Inc. | 2014-12-08 |
| NOVAFLEX + DELIVERY SYSTEM (P130009/S017) | Edwards Lifesciences, LLC | 2014-12-05 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD (P980016/S509) | Medtronic Cardiac Rhythm Disease Management | 2014-12-04 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S051) | Medtronic | 2014-12-04 |
| BRAVA CRT-D'S BRAVA QUAD CRT-D'S, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S473) | Medtronic Cardiac Rhythm Disease Management | 2014-12-04 |
| SETROX S LEAD, DEXTRUS, TILDA R, SAFIO S. (P950037/S145) | Biotronik, Inc. | 2014-12-03 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S045) | Medtronic Heart Valves | 2014-12-02 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S049) | Medtronic, Inc. | 2014-12-02 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S060) | Medtronic, Inc. | 2014-12-02 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S029) | Medtronic, Inc. | 2014-12-02 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S051) | Medtronic, Inc. | 2014-12-02 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (P040044/S058) | Cordis US Corporation | 2014-11-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S061) | Edwards Lifesciences, LLC | 2014-11-25 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S042) | Boston Scientific Corporation | 2014-11-25 |
| ENDURANT IIS STENT GRAFT SYSTEM (P100021/S042) | Medtronic Vascular | 2014-11-25 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S018) | Edwards Lifesciences, LLC | 2014-11-25 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S048) | Edwards Lifesciences, LLC | 2014-11-25 |
| MITROFLOW AORTIC PERICARDIAL HEART CALVE WITH PHOSPHOLIPID REDUCTION TREATMENT (P060038/S021) | Corcym Canada Corp | 2014-11-25 |
| ELUNA 8 HF-T; ENTOVIS HF, ENTOVIS HF-T, EPYRA 8 HF-T (P070008/S058) | Biotronik, Inc. | 2014-11-21 |
| EURO DR, DRT, SR, SR-T; EFFECTA D, DR, S, SR; ELUNA E DR-T PROMRI, 8 DRPROMRI; ELUNA 8 DR-T PROMRI; ELUNA 8 SR-T PROMRI; (P950037/S144) | Biotronik, Inc. | 2014-11-21 |
| PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUADRA, PROMOTE +, QUADRA ASSURA, UNIFY, UNIFY ASSURA AND UNIFY QUADRA FAMILY (P030054/S277) | ABBOTT MEDICAL | 2014-11-21 |
| ACCENT, ASSURITY, ASSURITY+ AND ENDURITY FAMILY OF PACEMAKERS (P880086/S250) | ABBOTT MEDICAL | 2014-11-21 |
| ANTHEM, ALLURE AND ALLURE QUADRA FAMILY OF CRT-P (P030035/S128) | ABBOTT MEDICAL | 2014-11-21 |
| IGOTIS 5 HF-T (DF-4), 7 HF-T (DF-4, LI); IFORIA 7 HF-T (DF4, GB) IIESTO 5 HF-TIESTO 5 HF-T (DF-4) (P050023/S082) | Biotronik, Inc. | 2014-11-21 |
| CURRENT, CURRENT ACCEL, CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICD DEVICES (P910023/S347) | ABBOTT MEDICAL | 2014-11-21 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN, ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S076) | W. L. Gore & Associates, Inc. | 2014-11-21 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S015) | W. L. Gore & Associates, Inc. | 2014-11-21 |
| FORTIFY, FORTIFY ASSURA FAMILY OF ICDS (P910023/S343) | ABBOTT MEDICAL | 2014-11-20 |
| QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILY OF CRT-DS (P030054/S274) | ABBOTT MEDICAL | 2014-11-20 |
| TRI VASCULAR, INC. OVATION /OVATION ABDOMINAL STENT GRAFT SYSTEM (P120006/S016) | Endologix, LLC | 2014-11-20 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P030031/S063) | Biosense Webster, Inc. | 2014-11-19 |
| COOLFLOW IRRIGATION PUMP (P990071/S029) | Biosense Webster, Inc. | 2014-11-19 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S057) | Zoll Manufacturing Corporation | 2014-11-19 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S042) | Medtronic Vascular | 2014-11-19 |
| THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P040036/S047) | Biosense Webster, Inc. | 2014-11-19 |
| NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, THERMOCOOL ST (P040036/S046) | Biosense Webster, Inc. | 2014-11-18 |
| NAVISTAR THERMOCOOL, CELSIUS THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL,CELSIUS RMT THERMOCOOL, THERMOCOOL (P030031/S062) | Biosense Webster, Inc. | 2014-11-18 |
| NAVISTAR DS, CELSIUS DS, EZ STEER NAV DS, NAVISTAR RMT DS, CELSIUS (P010068/S043) | Biosense Webster, Inc. | 2014-11-18 |
| NAVISTAR 4MM, NAVISTAR RMT 4MM, EZ STEER 4MM NAV (P990025/S042) | Biosense Webster, Inc. | 2014-11-18 |
| CELSIUS FLUTTERS, CELSIUS, CELSIUS RMT, EZ STEER 4MM NON-NAV, EZ STEER DS, CELSIUS FLUTTERS (P950005/S054) | Biosense Webster, Inc. | 2014-11-18 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S007) | Cardiva Medical, Inc. | 2014-11-17 |
| LUMAX 300/340 & 500/540 DR/DR-T/VR/VR-T ICD'S, LUMAX 540 VR-T DX ICD, KRONOS LV-T, LUMAX 300/340 & 500/540 HF/HF-T CRT-D (P050023/S077) | Biotronik, Inc. | 2014-11-17 |
| ETRINSA 8/6 DR-T/SR-T, ETRINSA 6 DR/SR, EPYRA 8/6 DR-T/SR-T, ELUNA 8 DR-T/SR-T DR/SR PRO MRI PACEMAKERS (P950037/S137) | Biotronik, Inc. | 2014-11-17 |
| ADVANTIO, INGENIO, VITALIO, FORMIO PACEMAKERS (N970003/S168) | Boston Scientific Corp | 2014-11-17 |
| ETRINSA 8 HF-T, EPYRA 8 HF-T, ELUNA 8 HF-T CRT-P'S (P070008/S053) | Biotronik, Inc. | 2014-11-17 |
| BELOS & LEXOS DR/DR-T/VR/VR-T ICD'S, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S058) | Biotronik, Inc. | 2014-11-17 |
| INVIVE CRT-PS, INTUA CRT-PS (P030005/S114) | Guidant Corp. | 2014-11-17 |
| EVERA S DR & SR,, EVERA XT DR & VR , MAXIMO II, PROTECTA , PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S (P980016/S502) | Medtronic Cardiac Rhythm Disease Management | 2014-11-14 |
| , BRAVA QUAD, CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S & XT, VIVA S & XT CRT-D'S (P010031/S466) | Medtronic Cardiac Rhythm Disease Management | 2014-11-14 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S015) | Edwards Lifesciences, LLC | 2014-11-14 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPPROSTHESIS, THEON WITH THERMAFIX TISSUE PROCESS; RSR, THEON RSR WITH (P860057/S129) | Edwards Lifesciences, LLC | 2014-11-14 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S060) | Edwards Lifesciences, LLC | 2014-11-14 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S047) | Edwards Lifesciences, LLC | 2014-11-14 |
| MEDTRONIC OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT (P990046/S039) | Medtronic Ats Medical, Inc. | 2014-11-13 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT-(MODEL 150) (P790007/S044) | Medtronic Heart Valves | 2014-11-12 |
| HANCOCK LOW POROSITY VALVED CONDUIT (MODEL 105) (P870078/S028) | Medtronic, Inc. | 2014-11-12 |
| HANCOCK II PORCINE BIOPROSTHESIS- (MODELS T505, T510) (P980043/S050) | Medtronic, Inc. | 2014-11-12 |
| MOSAIC PORCINE BIOPROSTHESIS- (MODELS 305. 310) (P990064/S059) | Medtronic, Inc. | 2014-11-12 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS(MODELS 995, 995CS, 995MS) (P970031/S048) | Medtronic, Inc. | 2014-11-12 |
| MEDTRONIC MODELS 2490H CARELINK REMOTE HOME MONITOR, 2020C CARELINK EXPRESS MONITOR, AND 2491 DDMA (P890003/S319) | Medtronic, Inc. | 2014-11-07 |
| MYCARELINK PATIENT MONITOR (P890003/S320) | Medtronic, Inc. | 2014-11-07 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, INTRINSIC 30 ICD, INTRINSIC ICD, MARQUIS ICD,MARQUIS V (P980016/S500) | Medtronic Cardiac Rhythm Disease Management | 2014-11-07 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, INSYNC III MARQUI (P010031/S464) | Medtronic Cardiac Rhythm Disease Management | 2014-11-07 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700) IPG, KAP (P980035/S392) | Medtronic, Inc. | 2014-11-07 |
| REPLY SR, REPLY DR, ESPIRIT SR, ESPIRIT DR (P950029/S098) | MicroPort CRM USA, Inc. | 2014-11-07 |
| DYNAGEN EL, INOGEN EL, ORIGEN EL ICDS (P960040/S332) | Boston Scientific | 2014-11-07 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S003) | Abbott Vascular (Idef Technologies Inc) | 2014-11-07 |
| INTENSIA VR 124, INTENSIA DR 154, INTENSIA CRT-D 174 (P980049/S103) | MicroPort CRM USA, Inc. | 2014-11-07 |
| ADAPTA, VERSA, SENSIA, ENPULSE E1/E2. KAPPA D/DR/VDD IPG'S (P980035/S391) | Medtronic, Inc. | 2014-11-07 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S248) | Medtronic, Inc. | 2014-11-07 |
| DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4 CRT-D (P010012/S371) | Boston Scientific Corp | 2014-11-07 |
| REVO MRI IPG (P090013/S154) | Medtronic, Inc. | 2014-11-07 |
| PARADYM VR 8250, PARADYM DR 8550, PARADYM CRT-D 8750, PARADYM RF VR 9250, PARADYM RF DR 9550, PARADYM M RF CRT-D 9750 (P060027/S070) | MicroPort CRM USA, Inc. | 2014-11-07 |
| LIVEWIRE TC AND SAFIRE BIDIRECTIONAL ABLATION CATHETER (P960016/S049) | St Jude Medical | 2014-11-06 |