| CARDIOMEMS HF SYSTEM (P100045/S001) | ABBOTT MEDICAL | 2014-08-29 |
| CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S113) | Medtronic Cardiac Rhythm Disease Management | 2014-08-29 |
| CAPSUREFIX MRI LEAD (P090013/S152) | Medtronic, Inc. | 2014-08-29 |
| PATIENT CABLE, SURGICAL CABLE (P820003/S130) | Medtronic Cardiac Rhythm Disease Management | 2014-08-29 |
| SELECTSECURE LEAD (P030036/S073) | Medtronic Cardiac Rhythm Disease Management | 2014-08-29 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD (P920015/S138) | Medtronic, Inc. | 2014-08-29 |
| ADAPTA, VERSA, SENSIA IPG ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S389) | Medtronic, Inc. | 2014-08-29 |
| FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE (P950020/S068) | Boston Scientific Corp | 2014-08-29 |
| TRANSVENE CS/SVC LEAD (P980050/S094) | Medtronic, Inc. | 2014-08-29 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, MODEL 4195 ATTAIN SUREFIX LEAD (P930039/S115) | Medtronic, Inc. | 2014-08-29 |
| CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD (P850089/S110) | Medtronic Cardiac Rhythm Disease Management | 2014-08-29 |
| CAPSURE VDD 2 (P890003/S317) | Medtronic, Inc. | 2014-08-29 |
| PRODIGY IPG (P890003/S316) | Medtronic, Inc. | 2014-08-29 |
| ANALYZER ADAPTOR, ANALYZER CABLE (P890003/S314) | Medtronic, Inc. | 2014-08-29 |
| ATTAIN ABILITY LEAD (P080006/S070) | Medtronic, Inc. | 2014-08-29 |
| ATTAIN BIPOLAR OTW LEAD, LED VENTRICULAR PACING LEAD (P010015/S247) | Medtronic, Inc. | 2014-08-29 |
| MODEL 4195 ATTAIN STARFIX LEAD (P060039/S061) | Medtronic, Inc. | 2014-08-29 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S076) | Boston Scientific Corp | 2014-08-28 |
| SAPIEN THV WITH RETROFLEX FOR INOPERABLE PATIENTS AND WITH RETROFLEX OR ASCENDRA FOR HIGH RISK OPERABLE (P100041/S056) | Edwards Lifesciences, LLC | 2014-08-28 |
| PARADYM VR/DR 8750 & VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101 & Z102) (P980049/S101) | MicroPort CRM USA, Inc. | 2014-08-27 |
| SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD (P920015/S139) | Medtronic, Inc. | 2014-08-27 |
| CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROCTECTA CRT-D,PROTECTA XT CRT-D (P010031/S460) | Medtronic Cardiac Rhythm Disease Management | 2014-08-27 |
| COGNIS, INCEPTA, ENERGEN, PUCTUA, DYNAGEN, INOGEN, ORIGEN; CRT-D'S (P960040/S328) | Boston Scientific | 2014-08-27 |
| FREEZOR MAX CARDIAC CRYOABLATION CATHETER (P100010/S037) | Medtronic Cryocath, LP | 2014-08-27 |
| ARCTIC FRONT ADVANCE CRYOBALLOON CATHETER (P100010/S042) | Medtronic Cryocath, LP | 2014-08-27 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S040) | Boston Scientific Corporation | 2014-08-27 |
| FREEZOR CARDIAC CRYOABLATION CATHETER, XTRA SURGICAL CRYOABLATION CATHETER, MAX SURGICAL CARDIAC CRYOABLATION CATHETER (P020045/S055) | Medtronic Cryocath, LP | 2014-08-27 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S095) | MicroPort CRM USA, Inc. | 2014-08-27 |
| PARADYM CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM CRT-D9750 (ZL102) (P060027/S068) | MicroPort CRM USA, Inc. | 2014-08-27 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S094) | MicroPort CRM USA, Inc. | 2014-08-27 |
| TRANSVENE CS/SVC LEAD (P980050/S095) | Medtronic, Inc. | 2014-08-27 |
| TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN, ORIGEN; ICD'S (P010012/S368) | Boston Scientific Corp | 2014-08-27 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S496) | Medtronic Cardiac Rhythm Disease Management | 2014-08-27 |
| NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD,ORIGEN EL (P960040/S320) | Boston Scientific | 2014-08-26 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S028) | Boston Scientific Corp | 2014-08-26 |
| NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D),DYNAGEN CRT-D,DYNAGEN X4 CRT-D,INOGEN CRT-D,INOGEN X4 CRT-D, (P010012/S359) | Boston Scientific Corp | 2014-08-26 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S017) | LeMaitre Vascular, Inc. | 2014-08-25 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S040) | Medtronic | 2014-08-25 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S103) | W. L. Gore & Associates, Inc. | 2014-08-22 |
| ARCTIC FRONT CRYOBALLOON CATHETER, ARCTIC FRONT ADVANCE CRYOBALLOON CATHETER (P100010/S041) | Medtronic Cryocath, LP | 2014-08-22 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S029) | Boston Scientific Corporation | 2014-08-22 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM CATHETER (P960016/S047) | St Jude Medical | 2014-08-22 |
| CVX-300 AND CVX-300-P EXCIMER LASER SYSTEMS (P910001/S073) | Spectranetics Corp. | 2014-08-21 |
| ATTAIN STARFIX LEAD (P060039/S060) | Medtronic, Inc. | 2014-08-20 |
| OPEN PIVOT HEART VALVE (OPHV) AND OPEN PIVOT AORTIC VALVED GRAFT (OPAVG) (P990046/S038) | Medtronic Ats Medical, Inc. | 2014-08-20 |
| ANCHORING SLEEVE KIT, SELECTSECURE LEAD (P030036/S072) | Medtronic Cardiac Rhythm Disease Management | 2014-08-20 |
| END CAP, EPICARDIAL PATCH LEAD, UPSIZING SLEEVE (P900061/S130) | Medtronic Cardiac Rhythm Disease Management | 2014-08-20 |
| TRANSVENE CS/SVC LEAD (P980050/S093) | Medtronic, Inc. | 2014-08-20 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S061) | Medtronic, Inc. | 2014-08-20 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA (P010031/S457) | Medtronic Cardiac Rhythm Disease Management | 2014-08-20 |
| PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEM (P060001/S022) | Medtronic Vascular, Inc. | 2014-08-20 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD (P850089/S109) | Medtronic Cardiac Rhythm Disease Management | 2014-08-20 |
| 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 I (P980016/S494) | Medtronic Cardiac Rhythm Disease Management | 2014-08-20 |
| Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD (P920015/S136) | Medtronic, Inc. | 2014-08-20 |
| CAPSURE VDD 2, VITATRON BRILLIANT S+ VDD LEAD, VITATRON BRILLIANT S+ VDD LEAD (P890003/S315) | Medtronic, Inc. | 2014-08-20 |
| EVERFLEX SELF EXPANDING PERIPHERAL STENT SYSTEM (P110023/S011) | Medtronic Vascular, Inc. | 2014-08-20 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S386) | Medtronic, Inc. | 2014-08-20 |
| ATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD (P010015/S245) | Medtronic, Inc. | 2014-08-20 |
| CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S112) | Medtronic Cardiac Rhythm Disease Management | 2014-08-20 |
| ATTAIN ABILITY LEAD (P080006/S069) | Medtronic, Inc. | 2014-08-20 |
| CAPSUREFIX LEAD (P930039/S113) | Medtronic, Inc. | 2014-08-20 |
| CAPSUREFIX MRI LEAD (P090013/S150) | Medtronic, Inc. | 2014-08-20 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S002) | Boston Scientific Corp | 2014-08-19 |
| MYNX ACE VASCULAR CLOSURE DEVICE (P040044/S057) | Cordis US Corporation | 2014-08-18 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D VIVA (P010031/S456) | Medtronic Cardiac Rhythm Disease Management | 2014-08-15 |
| ADVISA DR IPG, DR MRI IPG, ADAPTA, VERSA, SENSIA IPG, RELIA IPG (P980035/S387) | Medtronic, Inc. | 2014-08-15 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S013) | Abbott Vascular, Inc. | 2014-08-15 |
| ACUITY SPIRAL, EASYTRAK 2 LV-1, EASYTRAK 2 IS-1, EASYTRAK 3 LV-1, EASYTRAK 3 IS-1 (P010012/S365) | Boston Scientific Corp | 2014-08-15 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S014) | LeMaitre Vascular, Inc. | 2014-08-15 |
| ACUITY STEERABLE (P050046/S024) | Guidant Corp. | 2014-08-15 |
| EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD (P980016/S493) | Medtronic Cardiac Rhythm Disease Management | 2014-08-15 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S043) | Medtronic Heart Valves | 2014-08-14 |
| ZILVER VASCULAR STENT (P050017/S010) | Cook Ireland, Ltd. | 2014-08-14 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S049) | Medtronic, Inc. | 2014-08-14 |
| SPRINT QUATTRO LEAD (P920015/S137) | Medtronic, Inc. | 2014-08-14 |
| CAPSUREFIX LEAD, SUREFIX LEAD (P930039/S114) | Medtronic, Inc. | 2014-08-14 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S047) | Medtronic, Inc. | 2014-08-14 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S027) | Medtronic, Inc. | 2014-08-14 |
| MOSIAC PORCINE BIOPOROSTHESIS (P990064/S058) | Medtronic, Inc. | 2014-08-14 |
| REVO MRI IPG (P090013/S151) | Medtronic, Inc. | 2014-08-13 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S034) | Bard Peripheral Vascular | 2014-08-13 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S385) | Medtronic, Inc. | 2014-08-13 |
| NG3 DEVICES: ORIGEN , INOGEN, &, DYNAGEN CRT-D; PROGENGY DEVICES: PUNCTUA , ENERGEN , & INCEPTA CRT-D'S (P010012/S366) | Boston Scientific Corp | 2014-08-13 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S007) | ABBOTT MEDICAL | 2014-08-13 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S246) | Medtronic, Inc. | 2014-08-13 |
| EVERA S DR ICD, EVERA S VR ICS, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO 11 ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II D (P980016/S495) | Medtronic Cardiac Rhythm Disease Management | 2014-08-13 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG,RELIA IPG (P980035/S388) | Medtronic, Inc. | 2014-08-13 |
| NG3 DEVICES: ORIGEN, INOGEN, DYNAGEN ICDS; PROGENY DEVICES: PUNCTUA ICD, ENERGEN ICD, INCEPTA ICD (P960040/S326) | Boston Scientific | 2014-08-13 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S048) | Medtronic | 2014-08-13 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA (P010031/S459) | Medtronic Cardiac Rhythm Disease Management | 2014-08-13 |
| MEDTRONIC COREVALVE SYSTEM AND TRANSCATHETER AORTIC VALVE (P130021/S005) | Medtronic, Inc. | 2014-08-12 |
| BRAVA QUAD CRT-D, VIVA QUAD C CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D (P010031/S458) | Medtronic Cardiac Rhythm Disease Management | 2014-08-12 |
| CAP SURE VDD-2 LEAD, VITATRON BRILLIANT S+ VDD LEAD (P890003/S312) | Medtronic, Inc. | 2014-08-12 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S060) | Medtronic, Inc. | 2014-08-12 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S093) | MicroPort CRM USA, Inc. | 2014-08-12 |
| AFX VELA PROXIMAL ENDOGRAFT SYSTEM (P040002/S053) | Endologix, LLC | 2014-08-12 |
| CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD, CAPSURE SP NOVUS LEAD (P850089/S108) | Medtronic Cardiac Rhythm Disease Management | 2014-08-12 |
| CAPSURE SP NOVUS LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S111) | Medtronic Cardiac Rhythm Disease Management | 2014-08-12 |
| VENTAK PRX AND VENTAK MINI SYSTEMS (P910077/S144) | Boston Scientific | 2014-08-12 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S126) | Edwards Lifesciences, LLC | 2014-08-11 |