| PARADYM RF CRT-D9750 (P060027/S065) | MicroPort CRM USA, Inc. | 2014-06-27 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S020) | Syncardia Systems, LLC | 2014-06-26 |
| MICRONY CRT-P'S (P970013/S059) | ABBOTT MEDICAL | 2014-06-25 |
| CURRENT+, FORTIFY, FORTIFY ASSURA, AND ELLIPSE ICD'S (P910023/S337) | ABBOTT MEDICAL | 2014-06-25 |
| ACCENT, VERITY, IDENTITY, ZEPHYR, ASSURITY/+, ENDURITY CRT-P'S (P880086/S243) | ABBOTT MEDICAL | 2014-06-25 |
| PROMOTE+,UNIFY,UNIFY ASSURA,UNIFY QUADRA, & QUADRA ASSURA CRT-DS (P030054/S269) | ABBOTT MEDICAL | 2014-06-25 |
| ANTHEM AND ALLURE CRT-P'S (P030035/S121) | ABBOTT MEDICAL | 2014-06-25 |
| FREEDOM SOLO STENTLESS HEART VALVE (P130011) | Corcym Canada Corp | 2014-06-24 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P110023/S006) | Medtronic Vascular, Inc. | 2014-06-22 |
| QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S262) | ABBOTT MEDICAL | 2014-06-20 |
| LUMAX FAMILIES OF ICD'S & CRT-D'S, ILESTO & IFORNIA FAMILIES OF ICD'S & CRT-D'S (P050023/S072) | Biotronik, Inc. | 2014-06-20 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S404) | Medtronic Cardiac Rhythm Disease Management | 2014-06-20 |
| LUMOS FAMILY OF ICD'S (P000009/S056) | Biotronik, Inc. | 2014-06-20 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S065) | W. L. Gore & Associates, Inc. | 2014-06-20 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S096) | W. L. Gore & Associates, Inc. | 2014-06-20 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S443) | Medtronic Cardiac Rhythm Disease Management | 2014-06-20 |
| LATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM (P910077/S140) | Boston Scientific | 2014-06-20 |
| PROTECTA ICD & PROTECTA XT ICD (P980016/S481) | Medtronic Cardiac Rhythm Disease Management | 2014-06-20 |
| STRATOS, EVIA, & ENTOVIS FAMILIES OF CRT-P'S (P070008/S049) | Biotronik, Inc. | 2014-06-20 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S025) | Syncardia Systems, LLC | 2014-06-20 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S092) | W. L. Gore & Associates, Inc. | 2014-06-20 |
| PROTECTA CRT-D & PROTECTA XT CRT-D (P010031/S443) | Medtronic Cardiac Rhythm Disease Management | 2014-06-20 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S005) | W. L. Gore & Associates, Inc. | 2014-06-20 |
| CYLOS, PHILOS/PHILOS II, EVIA, ENTOVIA, ECURO, EFFECTA, & ESTELLA FAMILIES OF PACEMAKERS (P950037/S131) | Biotronik, Inc. | 2014-06-20 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S062) | W. L. Gore & Associates, Inc. | 2014-06-20 |
| ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD (P910023/S331) | ABBOTT MEDICAL | 2014-06-20 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S064) | W. L. Gore & Associates, Inc. | 2014-06-18 |
| EVERA S DR ICD , EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S485) | Medtronic Cardiac Rhythm Disease Management | 2014-06-18 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S095) | W. L. Gore & Associates, Inc. | 2014-06-18 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S046) | Endologix, LLC | 2014-06-18 |
| FORTIFY AND FORTIFY ASSURA ICDS (P910023/S338) | ABBOTT MEDICAL | 2014-06-18 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY. (MYNX PRODUCT FAMILY) (P040044/S054) | Cordis US Corporation | 2014-06-18 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S447) | Medtronic Cardiac Rhythm Disease Management | 2014-06-18 |
| UNIFY, UNIFY ASSURA, UNIFY QUADRA, AND QUADRA ASSURA CRT-DS (P030054/S270) | ABBOTT MEDICAL | 2014-06-18 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS,CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP (P860057/S125) | Edwards Lifesciences, LLC | 2014-06-18 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S004) | W. L. Gore & Associates, Inc. | 2014-06-18 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029) | Bard Peripheral Vascular, Inc. | 2014-06-17 |
| CAPSUREFIX LEAD (P930039/S109) | Medtronic, Inc. | 2014-06-17 |
| REVO MRI IPG (P090013/S143) | Medtronic, Inc. | 2014-06-17 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DRIPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S378) | Medtronic, Inc. | 2014-06-17 |
| BARD LIFESTENT VASCULAR STENT (P070014/S046) | Bard Peripheral Vascular, Inc. | 2014-06-17 |
| DYNAGEN, INOGEN, ORIGEN (P010012/S357) | Boston Scientific Corp | 2014-06-17 |
| BRAVA CRT-D, CONCETO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA S CRT-D, XT CRT-D (P010031/S446) | Medtronic Cardiac Rhythm Disease Management | 2014-06-17 |
| EVERA S DR ICD, VR ICD, XT DR ICDXT VR ICD, MAXIMO II ICD PROTECTA ICD, XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S484) | Medtronic Cardiac Rhythm Disease Management | 2014-06-17 |
| DYNAGEN, INOGEN, ORIGEN (P960040/S318) | Boston Scientific | 2014-06-17 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009) | Edwards Lifesciences, LLC | 2014-06-16 |
| CORDIS SMART CONTROL NITINOL STENT SYSTEMS (P020036/S029) | Cordis US Corporation | 2014-06-13 |
| MIRACLIP CLIP DELIVERY SYSTEM (P100009/S001) | ABBOTT MEDICAL | 2014-06-13 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S004) | AtriCure, Inc. | 2014-06-13 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S043) | Medtronic | 2014-06-13 |
| SMART CONTROL VASCULAR STENT SYSTEMS (P120002/S004) | Cordis US Corporation | 2014-06-13 |
| MEDTRONIC COREVALVE SYSTEM (P130021/S002) | Medtronic, Inc. | 2014-06-12 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S031) | Edwards Lifesciences, LLC | 2014-06-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S044) | Edwards Lifesciences, LLC | 2014-06-11 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S042) | Medtronic | 2014-06-11 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S005) | Bolton Medical, Inc. | 2014-06-11 |
| RX HERCULINK ELITE RENAL STENT SYSTEM (P110001/S011) | Abbott Vascular | 2014-06-06 |
| LIFE VEST WEARABLE DEFIBRILLATOR (P010030/S050) | Zoll Manufacturing Corporation | 2014-06-06 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S053) | Abbott Vascular | 2014-06-05 |
| GODRE TAG THORACIC ENDOPROSTHESIS (P040043/S060) | W. L. Gore & Associates, Inc. | 2014-06-04 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S086) | Boston Scientific Corp | 2014-06-04 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S100) | Boston Scientific Corp | 2014-06-04 |
| ZENITH AAA ENDOVASCULAR GRAFT (P020018/S052) | Cook, Inc. | 2014-06-04 |
| BARD ABLATION SYSTEM (P000020/S017) | Boston Scientific Corp | 2014-06-04 |
| NIRXCELL COCR CORNARY STENT ON RX (P110004/S006) | Medinol, Ltd. | 2014-06-04 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S099) | Boston Scientific Corp | 2014-06-03 |
| PROMUS PREMIER & PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS (P110010/S087) | Boston Scientific Corp | 2014-06-03 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S048) | Abbott Vascular | 2014-06-02 |
| ORIGEN, INOGEN,DYNAGEN, NG3 IMPLANTABLE CARDIOVESTER DEFIBRILLATOR (ICD) ORIGEN, INOGEN, DYNAGEN NG2.5 IMPLANTABLE CARDI (P960040/S317) | Boston Scientific | 2014-06-02 |
| ADAPTA, VERSA, SENSIA, IPG (P980035/S377) | Medtronic, Inc. | 2014-06-02 |
| NIRXCELL COCR CORONARY STENT ON RX (P110004/S004) | Medinol, Ltd. | 2014-06-02 |
| DYNAGEN, INOGEN, ORIGEN NG3 CARDIAC RESYNCHRONIZATION THERAPY DEFUBRILLATION DEFIBRILLATOR (CRT-D) (P010012/S356) | Boston Scientific Corp | 2014-06-02 |
| BLAZER II XP, BLAZER PRIME XP, INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S058) | Boston Scientific | 2014-05-30 |
| BLAZER II, BLAZER II HTD, BLAZER PRIME HTD (P920047/S070) | Boston Scientific Corp | 2014-05-30 |
| BRAVA CRT-D ; CONCERTO II CRT-D; CONSULTA ICD; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRT-D; VIVA S CRT-D; XT CRT- (P010031/S445) | Medtronic Cardiac Rhythm Disease Management | 2014-05-30 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (P110042/S035) | Boston Scientific Corporation | 2014-05-30 |
| EVERA S DR ICD; S VR ICD; EVERA XT DR ICD; XT VR ICD; MAXIMO II ICD; PROTECTA ICD; XT ICD; SECURA ICD; VIRTUOSO II DR/VR (P980016/S483) | Medtronic Cardiac Rhythm Disease Management | 2014-05-30 |
| CONSULTA CRT-P,SYNCRA CRT-P (P010015/S238) | Medtronic, Inc. | 2014-05-29 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S058) | ABBOTT MEDICAL | 2014-05-29 |
| BRAVA CRT-D, CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC II PROTECT ICD,INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD (P010031/S439) | Medtronic Cardiac Rhythm Disease Management | 2014-05-29 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S242) | ABBOTT MEDICAL | 2014-05-29 |
| EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, INTRINSIC 30 ICD,INTRINSIC ICD,MARQUIS DR ICD, MARQUIS (P980016/S478) | Medtronic Cardiac Rhythm Disease Management | 2014-05-29 |
| REVO MRI IPG (P090013/S141) | Medtronic, Inc. | 2014-05-29 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S265) | ABBOTT MEDICAL | 2014-05-29 |
| ADVISA DR IPG AND ADVISA DR MRI IPG (P980035/S376) | Medtronic, Inc. | 2014-05-29 |
| REVO MRI IPG (P090013/S139) | Medtronic, Inc. | 2014-05-29 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S034) | Boston Scientific Corporation | 2014-05-29 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S119) | Abbott Vascular, Inc. | 2014-05-29 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, (P110019/S060) | Abbott Vascular | 2014-05-29 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S239) | Medtronic, Inc. | 2014-05-29 |
| FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-PS (P030035/S120) | ABBOTT MEDICAL | 2014-05-29 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S088) | St. Jude Medical, Inc. | 2014-05-29 |
| MYCARELINK PATIENT MONITOR (P890003/S307) | Medtronic, Inc. | 2014-05-29 |
| ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG, ENPULSE E1 IPG,ENPULSE E2 IPG, KAPPA D(KAPPA 700)IPG, KAPPA D(K (P980035/S373) | Medtronic, Inc. | 2014-05-29 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM, Q-GUIDE ELECTRODE INSERTION TOOL (P110042/S033) | Boston Scientific Corporation | 2014-05-28 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S033) | W. L. Gore & Associates, Inc. | 2014-05-28 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S061) | W. L. Gore & Associates, Inc. | 2014-05-28 |
| CAPSUREFIX MRI LEAD (P090013/S142) | Medtronic, Inc. | 2014-05-28 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045) | ABBOTT MEDICAL | 2014-05-28 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S038) | W. L. Gore & Associates, Inc. | 2014-05-28 |