| VERTICALLY INTEGRATING BATTERY FEEDTHRU ASSEMBLY (P960040/S325) | Boston Scientific | 2014-08-11 |
| CAPSUREFIX MRI LEAD (P090013/S148) | Medtronic, Inc. | 2014-08-08 |
| SPRINT QUATTRO LEAD (P920015/S135) | Medtronic, Inc. | 2014-08-08 |
| CAPSURE SENSE LEAD (P830061/S110) | Medtronic Cardiac Rhythm Disease Management | 2014-08-08 |
| CAPSUREFIX NOVUS LEAD (P930039/S112) | Medtronic, Inc. | 2014-08-08 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S003) | Cardiva Medical, Inc. | 2014-08-07 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S005) | Edwards Lifesciences, LLC | 2014-08-07 |
| FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC C (P020045/S057) | Medtronic Cryocath, LP | 2014-08-07 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S003) | Edwards Lifesciences, LLC | 2014-08-07 |
| FREEZOR MAX CARDIAC CRYOABLATION CATHETER (P100010/S039) | Medtronic Cryocath, LP | 2014-08-07 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S026) | Syncardia Systems, LLC | 2014-08-07 |
| LIFEVEST DEVICE (P010030/S055) | Zoll Manufacturing Corporation | 2014-08-07 |
| PROMUS ELEMENT PLUS/ PREMIER EVEROLIMUS- ELUTING PLATINUN CHROMIUM CORONARY STENT SYSTEM (P110010/S091) | Boston Scientific Corp | 2014-08-05 |
| ION PACLITITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S103) | Boston Scientific Corp | 2014-08-05 |
| HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HM II LVAS) (P060040/S031) | ABBOTT MEDICAL | 2014-08-05 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S054) | Edwards Lifesciences, LLC | 2014-08-04 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S001) | Edwards Lifesciences, LLC | 2014-08-04 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S001) | Boston Scientific Corp | 2014-08-04 |
| MEDTRONIC ATTAIN STARFIX MODEL 4195 LEADS (P060039/S056) | Medtronic, Inc. | 2014-08-04 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES (P860057/S118) | Edwards Lifesciences, LLC | 2014-08-04 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S041) | Edwards Lifesciences, LLC | 2014-08-04 |
| ELLIPSE FAMILY OF ICDS (P910023/S339) | ABBOTT MEDICAL | 2014-08-01 |
| NAVISTAR THERMOCOOL (P040036/S043) | Biosense Webster, Inc. | 2014-08-01 |
| NIT-OCCLUD PDA (P120009/S001) | Pfm Medical, Inc. | 2014-08-01 |
| ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD (P080006/S068) | Medtronic, Inc. | 2014-08-01 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S142) | Boston Scientific Corp | 2014-08-01 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (ROTABLATOR CONSOLE AND FOOT PEDAL) (P900056/S132) | Boston Scientific Corp | 2014-08-01 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S043) | Medtronic Vascular | 2014-07-31 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S010) | W. L. Gore & Associates, Inc. | 2014-07-31 |
| INTEGRITY CORONARY STENT SYSTEM (P030009/S079) | Medtronic, Ireland | 2014-07-31 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S070) | W. L. Gore & Associates, Inc. | 2014-07-31 |
| VENTAK AV/PRIZM DR/VR, VITALITY, CONFIENT, TELIGEN, PUNCTUA, ENERGEN, & INCEPTA ICD'S (P960040/S323) | Boston Scientific | 2014-07-30 |
| SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEADS (P960006/S043) | Boston Scientific | 2014-07-30 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S490) | Medtronic Cardiac Rhythm Disease Management | 2014-07-30 |
| AFX ENDOVASCULAR AAA SYSTEM (ACCESSORY STENT GRAFT DELIVERY SYSTEM (P040002/S049) | Endologix, LLC | 2014-07-30 |
| CONTAK RENEWAL TR, INVIVE AND INTUA CRT-P'S (P030005/S112) | Guidant Corp. | 2014-07-30 |
| THIN/LINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS (P960004/S066) | Boston Scientific | 2014-07-30 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (P040044/S056) | Cordis US Corporation | 2014-07-30 |
| VENTAK PRX AND VENTAK MINI (P910077/S145) | Boston Scientific | 2014-07-30 |
| ENDOTAK LEAD SYSTEM (P910073/S127) | Boston Scientific | 2014-07-30 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S452) | Medtronic Cardiac Rhythm Disease Management | 2014-07-30 |
| VENTAK (P830060/S080) | Boston Scientific | 2014-07-30 |
| CONTAK CD, EASYTRAK, LIVIAN, COGNIS, ACUITY SPIRAL, ENERGEN, PUNCTUA, & INCEPTA CRT-D'S (P010012/S363) | Boston Scientific Corp | 2014-07-30 |
| SELUTE LEAD SYSTEM (P950001/S027) | Boston Scientific | 2014-07-30 |
| VENTAK P2 PACEMAKER (P930035/S027) | Boston Scientific | 2014-07-30 |
| MEDTRONIC 3F AORTIC BIOPROSTHESIS MODEL 1000 (P060025/S013) | Medtronic, Inc. | 2014-07-30 |
| PULSAR, PULSAR MAX, INSIGNIA, ALTRUA, ADVANTIO & INGENIO PACEMAKERS (N970003/S166) | Boston Scientific Corp | 2014-07-30 |
| SPRINT QUATTRO LEAD (P920015/S134) | Medtronic, Inc. | 2014-07-28 |
| DYNAGEN, INOGEN, ORIGEN EL ICD'S AND DYNAGEN, INOGEN, ORIGEN MINI ICD'S (P960040/S324) | Boston Scientific | 2014-07-28 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S383) | Medtronic, Inc. | 2014-07-28 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S092) | MicroPort CRM USA, Inc. | 2014-07-28 |
| DYNAGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4CRT-D, OGIGEN CRT-D. X4 CRT-D (P010012/S364) | Boston Scientific Corp | 2014-07-28 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S036) | ABBOTT MEDICAL | 2014-07-27 |
| ARTIC FRONT CYROABLATION CATHETER, ARTIC FRONT ADVANCE CRYOABLATION CATHETER (P100010/S040) | Medtronic Cryocath, LP | 2014-07-25 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER & XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, 9F FREEZOR MAX SURGICAL CARDIAC (P020045/S058) | Medtronic Cryocath, LP | 2014-07-25 |
| BRAVA QUAD CRT-D, VIVA QUAD C CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D (P010031/S453) | Medtronic Cardiac Rhythm Disease Management | 2014-07-24 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S140) | Boston Scientific Corp | 2014-07-24 |
| FAMILY OF MERLIN@HOME TRANSMITTERS (P910023/S336) | ABBOTT MEDICAL | 2014-07-24 |
| VIVA CRT-P (P010015/S243) | Medtronic, Inc. | 2014-07-24 |
| FAMILY OF MERLIN@HOME TRANSMITTERS (P030054/S268) | ABBOTT MEDICAL | 2014-07-24 |
| HEART LASER CO2 TMR SYSTEM (P950015/S012) | Laser Engineering Heart, Inc. | 2014-07-23 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S047) | Medtronic, Inc. | 2014-07-23 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S046) | Medtronic, Inc. | 2014-07-23 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S056) | Medtronic, Inc. | 2014-07-23 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S042) | Medtronic Heart Valves | 2014-07-23 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S026) | Medtronic, Inc. | 2014-07-23 |
| EVERA S DR IC&, VR, XT DR, & XT VR ICD, MAXIMO II ICD, PROTECTA & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S491) | Medtronic Cardiac Rhythm Disease Management | 2014-07-22 |
| BRAVA/ BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT ,VIVA QUAD S/XT/S CRT-D'S (P010031/S454) | Medtronic Cardiac Rhythm Disease Management | 2014-07-22 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S102) | W. L. Gore & Associates, Inc. | 2014-07-21 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS (P110010/S083) | Boston Scientific Corp | 2014-07-18 |
| INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER (P020025/S063) | Boston Scientific | 2014-07-18 |
| LIFE STENT VASCULAR STENT SYSTEMS (P070014/S044) | Bard Peripheral Vascular, Inc. | 2014-07-18 |
| QUADRA ASSURA, UNIFY, UNIFY ASSURA AND UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S272) | ABBOTT MEDICAL | 2014-07-18 |
| FORTIFY AND FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S341) | ABBOTT MEDICAL | 2014-07-18 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S063) | Boston Scientific Corp | 2014-07-18 |
| FREEZOR CARDIAC CRYOABLATION CATHETER; FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE (P020045/S054) | Medtronic Cryocath, LP | 2014-07-17 |
| CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, & PROTECTA XT CRT-D'S (P010031/S449) | Medtronic Cardiac Rhythm Disease Management | 2014-07-17 |
| MAXIMO II, PROTECTA, PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S (P980016/S487) | Medtronic Cardiac Rhythm Disease Management | 2014-07-17 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS (P060040/S037) | ABBOTT MEDICAL | 2014-07-17 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S091) | MicroPort CRM USA, Inc. | 2014-07-16 |
| REOCOR S/D EXTERNAL PACEMAKER (P950037/S135) | Biotronik, Inc. | 2014-07-16 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S039) | Medtronic Vascular | 2014-07-16 |
| LATITUDE NXT PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.0 (P910077/S143) | Boston Scientific | 2014-07-16 |
| COGNIS, PROGENY CRT-D AND NG CRT-D MODELS (P010012/S355) | Boston Scientific Corp | 2014-07-16 |
| TELIGEN, PROGENY ICD AND NG ICD MODELS (P960040/S316) | Boston Scientific | 2014-07-16 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S006) | ABBOTT MEDICAL | 2014-07-16 |
| CAPSUREFIX NOVUS LEAD 4076, CAPSUREFIX NOVUS LEAD 5076 (P930039/S111) | Medtronic, Inc. | 2014-07-16 |
| CAPSUREFIX MRI SURESCAN LEAD 5086MRI (P090013/S146) | Medtronic, Inc. | 2014-07-16 |
| CAPSURE SENSE BIPOLAR LEAD 4074, CAPSURE SENSE BIPOLAR LEAD 4574 (P830061/S109) | Medtronic Cardiac Rhythm Disease Management | 2014-07-16 |
| PARADYM VR 8750, PARADYM DR 8750,PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF VR 9750, PARADYM RF DR 9750 (P980049/S100) | MicroPort CRM USA, Inc. | 2014-07-16 |
| PARADYM CRT-D 8750,PARADYM RF CRT-D 9750 (ZL101), PARADYM RF CRT-D (ZL102) (P060027/S067) | MicroPort CRM USA, Inc. | 2014-07-16 |
| ADAPTA, VERSA, AND SENSIA IPG'S (P980035/S381) | Medtronic, Inc. | 2014-07-16 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL (P060038/S020) | Corcym Canada Corp | 2014-07-15 |
| AFX BIFURCATED STENT GRAFT DELIVERY SYSTEM (P040002/S048) | Endologix, LLC | 2014-07-14 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S051) | Zoll Manufacturing Corporation | 2014-07-14 |
| INTELLATIP MIFI FILTER MODULE, INTELLATIP MIFI REFERENCE CABLE (P020025/S062) | Boston Scientific | 2014-07-14 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S015) | LeMaitre Vascular, Inc. | 2014-07-14 |
| ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S380) | Medtronic, Inc. | 2014-07-11 |
| SELOX, TILDA, SOLOX (P950037/S136) | Biotronik, Inc. | 2014-07-11 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S046) | Medtronic, Inc. | 2014-07-11 |