| EASYTRAK 2+ IS-1 CORONARY VENOUS STEROID ELUTING DUAL ELECTRODE PACE/SENSE LEADS (P010012/S380) | Boston Scientific Corp | 2015-01-21 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, (P010031/S479) | Medtronic Cardiac Rhythm Disease Management | 2015-01-21 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- MONORAIL AND ION PACLITAXEL-ELUTING CORONAY STENT SYSTEM- OVER THE WIRE (P100023/S104) | Boston Scientific Corp | 2015-01-21 |
| NIT-OCCLUD SYSTEM (P120009/S002) | Pfm Medical, Inc. | 2015-01-21 |
| PROTEGE GPS SELF EXPANDING PERIPHERAL STENT SYSTEM (P060001/S020) | Medtronic Vascular, Inc. | 2015-01-21 |
| 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 (P980016/S515) | Medtronic Cardiac Rhythm Disease Management | 2015-01-21 |
| MTROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S022) | Corcym Canada Corp | 2015-01-21 |
| PERCLOSE PROGLIDE SUTURE- MEDIATED CLOSURE SYSTEM, PERCLOSE A-T SUTURE-MEDIATED CLOSURE SYSTEM (P960043/S089) | Abbott Vascular, Inc. | 2015-01-20 |
| LIVEWIRE TC ABLATION CATHETERS (P960016/S052) | St Jude Medical | 2015-01-15 |
| REBEL MONORAIL AND OVER-THE-WIRE PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S008) | Boston Scientific Corp | 2015-01-15 |
| INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S066) | Boston Scientific | 2015-01-15 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM,PROMUS PREMIER EVEROLIMUS-ELUTING PLATINU (P110010/S101) | Boston Scientific Corp | 2015-01-14 |
| TRIVASCULAR, INC OVATION/OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S017) | Endologix, LLC | 2015-01-14 |
| ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S112) | Boston Scientific Corp | 2015-01-14 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S007) | Boston Scientific Corp | 2015-01-14 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S278) | ABBOTT MEDICAL | 2015-01-13 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S251) | ABBOTT MEDICAL | 2015-01-13 |
| ELLIPSE / FORTIFY ASSURA FAMILY OF ICD'S (P910023/S348) | ABBOTT MEDICAL | 2015-01-13 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S011) | Cook Ireland, Ltd. | 2015-01-13 |
| FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-P'S (P030035/S129) | ABBOTT MEDICAL | 2015-01-13 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S005) | Cardiva Medical, Inc. | 2015-01-12 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIIAL AORTIC BIOPROSTHESIS, THEON PERICARDINAL AORTIC BIOPROSTHESIS WITH THERMAFIX T (P860057/S130) | Edwards Lifesciences, LLC | 2015-01-12 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S006) | Abbott Vascular (Idef Technologies Inc) | 2015-01-09 |
| MYNX ACE VASCULAR CLOSURE DEVICE (P040044/S060) | Cordis US Corporation | 2015-01-09 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S340) | Boston Scientific | 2015-01-09 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S008) | Cardiva Medical, Inc. | 2015-01-09 |
| THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S061) | Cordis US Corporation | 2015-01-09 |
| CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P010012/S381) | Boston Scientific Corp | 2015-01-09 |
| SPECTRANETICS EXCIMER CORONARY LASER ATHERECTOMY (ELCA) CATHETERS (P910001/S076) | Spectranetics Corp. | 2015-01-08 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S014) | W. L. Gore & Associates, Inc. | 2015-01-08 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S074) | W. L. Gore & Associates, Inc. | 2015-01-08 |
| SPECTRANETICS LASER SHEATHS (SLS) (P960042/S051) | Spectranetics (Philips) | 2015-01-08 |
| ZILVER FLEX 35 VASCULAR STENT (P050017/S009) | Cook Ireland, Ltd. | 2015-01-07 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S075) | Spectranetics Corp. | 2015-01-07 |
| ZILVER PTX DRUG ELUTING PERIPHERAL STENT (P100022/S010) | Cook Ireland, Ltd. | 2015-01-07 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA,ORIGEN, INOGEN, DYNAGEN, AUTOGEN, (CRT-D RESYNCHRONIZATION DEVICES (P010012/S377) | Boston Scientific Corp | 2015-01-06 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S008) | Medtronic, Ireland | 2015-01-06 |
| LATITUDE CONSULT SYSTEM (P910077/S148) | Boston Scientific | 2015-01-06 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S096) | MicroPort CRM USA, Inc. | 2015-01-06 |
| DYNAGEN, INOGEN, ORIGEN ICDS (P960040/S341) | Boston Scientific | 2015-01-06 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S039) | W. L. Gore & Associates, Inc. | 2015-01-06 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, ALTRUA 2 (PACEMAKER DEVICES) (N970003/S169) | Boston Scientific Corp | 2015-01-06 |
| CAPSUREFIX NOVUS LEAD AND VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S122) | Medtronic, Inc. | 2015-01-06 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN ICD DEVICES (P960040/S337) | Boston Scientific | 2015-01-06 |
| DYNAGEN, INOGEN, ORIGEN CRT-DS (P010012/S382) | Boston Scientific Corp | 2015-01-06 |
| INVIVE, INLIVEN, INTUA, VALITUDE, VALITUDE X4 (CRT-P RESYNCHRONIZATION DEVICES (P030005/S115) | Guidant Corp. | 2015-01-06 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S047) | Endologix, LLC | 2014-12-31 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax (P140010) | Medtronic, Inc. | 2014-12-30 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S402) | Medtronic, Inc. | 2014-12-23 |
| REPLY SR/ ESPRIT SR, REPLY DR/ ESPRIT DR FAMILY OF PACEMAKERS (P950029/S101) | MicroPort CRM USA, Inc. | 2014-12-23 |
| ENDURITY FAMILY OF PACEMEKERS (P880086/S248) | ABBOTT MEDICAL | 2014-12-22 |
| ALLURE AND ALLURE QUADRA FAMILY OF CRT-P'S (P030035/S126) | ABBOTT MEDICAL | 2014-12-22 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S009) | ABBOTT MEDICAL | 2014-12-22 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, (P010031/S475) | Medtronic Cardiac Rhythm Disease Management | 2014-12-19 |
| ORIGEN, ORIGEN X4,DYNAGEN,DYNAGEN X4,INOGEN,INOGEN X4 CRT-DS (P010012/S379) | Boston Scientific Corp | 2014-12-19 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD (P980016/S512) | Medtronic Cardiac Rhythm Disease Management | 2014-12-19 |
| ENDURANT, ENDURANT II, ENDURANT II AORTO -UNI-ILIAC (AUI) AND ENDURANT II'S STENT GRAFT SYSTEM (P100021/S043) | Medtronic Vascular | 2014-12-19 |
| MAESTRO 4000 CARDIAC ABLATION SYSTEM (P020025/S060) | Boston Scientific | 2014-12-19 |
| MAESTRO 4000 CARDIAC ABLATION SYSTEM (P980003/S052) | Boston Scientific Corp | 2014-12-19 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S403) | Medtronic, Inc. | 2014-12-19 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S254) | Medtronic, Inc. | 2014-12-19 |
| REVO MRI IPG (P090013/S163) | Medtronic, Inc. | 2014-12-19 |
| 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 IC (P980016/S511) | Medtronic Cardiac Rhythm Disease Management | 2014-12-19 |
| ORIGEN EL, ORIGEN MINI, DYNAGEN EL , DYNAGEN MINI,INOGEN EL,INOGEN MINI,INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S338) | Boston Scientific | 2014-12-19 |
| ENDURANT, ENDURANT 11, ENDURANT IIS STENT GRAFT SYSTEM AND ENDURANT II AORTO-UNI-ILIAC(AUI) STENT GRAFT SYSTEM (P100021/S044) | Medtronic Vascular | 2014-12-19 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D AND VIVA QUAD XT CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S476) | Medtronic Cardiac Rhythm Disease Management | 2014-12-19 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S054) | Medtronic | 2014-12-19 |
| MAESTRO 4000 CARDIAC ABLATION SYSTEM (P920047/S072) | Boston Scientific Corp | 2014-12-19 |
| REGENT MECHANICAL HEART VALVE, STANDARD MECHANICAL HEART VALVE, MASTERS MECHANICAL HEART VALVE (P810002/S092) | ABBOTT MEDICAL | 2014-12-18 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S046) | Medtronic Vascular | 2014-12-18 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S100) | Boston Scientific Corp | 2014-12-18 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S111) | Boston Scientific Corp | 2014-12-18 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- OVER THE WIRE; ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM-MONORAIL (P100023/S110) | Boston Scientific Corp | 2014-12-18 |
| OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S013) | Endologix, LLC | 2014-12-18 |
| TRIVASCULAR, INC OVATION ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S018) | Endologix, LLC | 2014-12-18 |
| QUICK-CLOSE VASCULAR SUTURING SYSTEM (P080029/S002) | Cardiva Medical, Inc. | 2014-12-18 |
| GORE TAG THORACIC ENDOPROTHESIS (P040043/S070) | W. L. Gore & Associates, Inc. | 2014-12-17 |
| MITRACLIP DELIVERY SYSTEM (P100009/S008) | ABBOTT MEDICAL | 2014-12-17 |
| CHILLI II COOLED ABLATION SYSTEM (P980003/S055) | Boston Scientific Corp | 2014-12-17 |
| BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS (P920047/S075) | Boston Scientific Corp | 2014-12-17 |
| BLAZER II XP TEMPERATURE ABLATION CATHETER (P020025/S065) | Boston Scientific | 2014-12-17 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S048) | Medtronic Vascular | 2014-12-16 |
| PARADYM CRT-D 8750; PARADYM RF CRT-D 9750; PARADYM RF BCRT-D9750; INTENSIA CRT-D (P060027/S071) | MicroPort CRM USA, Inc. | 2014-12-16 |
| PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750; RF DR 9750; RF VR 9750; RF DR 9750; INTENSIA VR ICD, INTENSIA DR (P980049/S104) | MicroPort CRM USA, Inc. | 2014-12-16 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S074) | Spectranetics Corp. | 2014-12-16 |
| REPLY SR, REPLY DE, ESPRIT DR (P950029/S100) | MicroPort CRM USA, Inc. | 2014-12-16 |
| REPLY/ESPRIT PACEMAKERS (P950029/S099) | MicroPort CRM USA, Inc. | 2014-12-15 |
| PROMOTE ACCEL, PROMOTE+ FAMILIES OF CRT-D DEVICES (P030054/S279) | ABBOTT MEDICAL | 2014-12-15 |
| REGENT MECHANICAL HEART VALVE, STANDARD AND MASTERS MECHANICAL HEART VALVE (P810002/S091) | ABBOTT MEDICAL | 2014-12-15 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S019) | Edwards Lifesciences, LLC | 2014-12-15 |
| CURRENT ACCEL, CURRENT+ FAMILES OF ICD DEVICES (P910023/S349) | ABBOTT MEDICAL | 2014-12-15 |
| MEDTRONIC COREVALVE (R) SYSTEM (P130021/S009) | Medtronic, Inc. | 2014-12-15 |
| REVO MRI IPG (P090013/S162) | Medtronic, Inc. | 2014-12-12 |
| PRODIGY IPG (P890003/S325) | Medtronic, Inc. | 2014-12-12 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S143) | Boston Scientific Corp | 2014-12-12 |
| SMARTABLATE SYSTEM (P990071/S030) | Biosense Webster, Inc. | 2014-12-12 |
| ORIGEN, ORIGEN X4,DYNAGEN,DYNAGEN X4,INOGEN,INOGEN X4 CRT-DS (P010012/S378) | Boston Scientific Corp | 2014-12-12 |
| ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S401) | Medtronic, Inc. | 2014-12-12 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S008) | Bolton Medical, Inc. | 2014-12-12 |
| ORIGEN EL, ORIGEN MINI, DYNAGEN EL , DYNAGEN MINI,INOGEN EL,INOGEN MINI,INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S339) | Boston Scientific | 2014-12-12 |