| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S114) | W. L. Gore & Associates, Inc. | 2015-05-27 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S115) | W. L. Gore & Associates, Inc. | 2015-05-27 |
| CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P (P010015/S270) | Medtronic, Inc. | 2015-05-27 |
| MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM (P140002) | Terumo Medical Corporation | 2015-05-22 |
| CARDIOMEMS HF SYSTEM (P100045/S005) | ABBOTT MEDICAL | 2015-05-22 |
| OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT (P120006/S019) | Endologix, LLC | 2015-05-21 |
| THERAPY DUAL 8 ABLATION CATHETER, THERAPY 8 MM THERMISTOR , SAFIRE TX ABLATION CATHETERS & GENERATORS (P040042/S030) | Irvine Biomedical,Inc.(Ibi) | 2015-05-20 |
| THERAPY ABLATION CATHETER INCLUDING BI-DIRECTIONAL CATHETER AND THERAPY 4MM THERNISTOR ABLATION CATHETER (P040014/S025) | Irvine Biomedical, Inc. | 2015-05-20 |
| THERAPY COOL PATH DUO ABLATION CATHETER AND THERAPY COOL FLEX ABLATION CATHETER (P110016/S017) | ABBOTT MEDICAL | 2015-05-20 |
| THERAPY COOL PATH ABLATION CATHETERS (INCLUDING ALL BRAID MODELS) (P060019/S031) | Irvine Biomedical, Inc. | 2015-05-20 |
| VALITUDE CRT-P (P030005/S121) | Guidant Corp. | 2015-05-19 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 PACEMAKERS (N970003/S173) | Boston Scientific Corp | 2015-05-19 |
| VALITUDE CRT-P (P030005/S120) | Guidant Corp. | 2015-05-19 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 PACEMAKERS (N970003/S174) | Boston Scientific Corp | 2015-05-19 |
| INGENIO 2 CRT-P DEVICES (P030005/S119) | Guidant Corp. | 2015-05-19 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026) | Boston Scientific Corporation | 2015-05-18 |
| MEDTRONIC OPEN PIVOT AORTIC VALVED GRAFT (P990046/S040) | Medtronic Ats Medical, Inc. | 2015-05-15 |
| CAROTID WALLSTENT ENDOPROSTHESIS (P050019/S021) | Boston Scientific Corp | 2015-05-15 |
| ADAPTA,VERSA,SENSIA IPG, RELIA IPG (P980035/S422) | Medtronic, Inc. | 2015-05-14 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S044) | Boston Scientific Corp | 2015-05-14 |
| CARDIOMESSENGER, RELIATY, RENAMIC, REOCOR (P950037/S152) | Biotronik, Inc. | 2015-05-14 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) (P130005/S004) | Cardiovascular Systems, Inc. | 2015-05-14 |
| CAPSURE SENSE LEAD (P830061/S120) | Medtronic Cardiac Rhythm Disease Management | 2015-05-14 |
| NIRXCELL COCR-CORONARY STENT ON RX SYSTEM (P110004/S010) | Medinol, Ltd. | 2015-05-14 |
| ASSURITY, ASSURITY+ AND ENDURITY FAMILY OF PACEMAKER DEVICES (P880086/S256) | ABBOTT MEDICAL | 2015-05-14 |
| CAPSUREFIX MRI LEAD (P090013/S185) | Medtronic, Inc. | 2015-05-14 |
| CAPSUREFIX NOVUS LEAD (P930039/S128) | Medtronic, Inc. | 2015-05-14 |
| ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES (P030035/S134) | ABBOTT MEDICAL | 2015-05-14 |
| CARDIOMESSENGER (P050023/S088) | Biotronik, Inc. | 2015-05-14 |
| FINELINE II PACE/SENSE LEAD (P960004/S068) | Boston Scientific | 2015-05-14 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S008) | Abbott Vascular (Idef Technologies Inc) | 2015-05-12 |
| ROTABLATOR RATATIONAL ANGIOPLASTY SYSTEM (P900056/S144) | Boston Scientific Corp | 2015-05-12 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S054) | St Jude Medical | 2015-05-11 |
| BLAZER II, BLAZER II HTD, BLAZER PRIME HTD (P920047/S079) | Boston Scientific Corp | 2015-05-11 |
| BLAZER PRIME XP, BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S070) | Boston Scientific | 2015-05-11 |
| CRYOCONSOLE (P020045/S064) | Medtronic Cryocath, LP | 2015-05-11 |
| MITRACLIP CLIP DELIVERY SYSTEM, MITRACLIP STEERABLE GUIDE CATHETER (P100009/S011) | ABBOTT MEDICAL | 2015-05-07 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S073) | W. L. Gore & Associates, Inc. | 2015-05-07 |
| GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S077) | W. L. Gore & Associates, Inc. | 2015-05-07 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S016) | W. L. Gore & Associates, Inc. | 2015-05-07 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S113) | W. L. Gore & Associates, Inc. | 2015-05-07 |
| ENDURANT II STENT GRAFT SYSTEM, ENDURANT IIS STENT GRAFT SYSTEM (P100021/S047) | Medtronic Vascular | 2015-05-06 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC MAXIMO ICD, MAXIMO II CRT-D, PROTECTA CRT-D, (P010031/S501) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| ANCHORING SLEEVE KIT, SELECTSECURE LEAD (P030036/S078) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ (P830061/S121) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| MEDTRONIC MODEL 25000 MY CARELINK SMART READER (P890003/S328) | Medtronic, Inc. | 2015-05-04 |
| CAPSUREFIX MRI LEAD, REVO MRI SURESCAN IPG (P090013/S186) | Medtronic, Inc. | 2015-05-04 |
| CAPSURE VDD 2 LEAD,PRODIGY IPG,SERVICE KIT-PACEMAKER REPAIR KIT,VITATRON BRILLIANT S+ VDD LEAD (P890003/S331) | Medtronic, Inc. | 2015-05-04 |
| VIRTUOSO,SECURA, MAXIMO II ,VIRTUOSO II , PROTECTA XT ,PROTECTA VT,EVERA (XT/S) ,EVERA S AND XT VR AND DR'S (P980016/S535) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| ADAPTA, VERSA,SENSIA IPG,ADVISA (DR/DR MRI) IPGS,ENRHYTHM MRI,ENPULSE (E1/E2) IPG,KAPPA D(700/900) IPG,KAPPA DR(650) IPG (P980035/S415) | Medtronic, Inc. | 2015-05-04 |
| END CAP,EPICARDIAL PATCH LEAD ,UPSIZING SLEEVE (P900061/S135) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| REVO MRI (P090013/S179) | Medtronic, Inc. | 2015-05-04 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S064) | Medtronic, Inc. | 2015-05-04 |
| TRANSVENE CS/SVC LEAD (P980050/S100) | Medtronic, Inc. | 2015-05-04 |
| RF CONTACTR,RF ENHANCR II,RF CONDUCTR,RF MARINR 5F,RF MARINR 7FR (P930029/S051) | Medtronic, Inc. | 2015-05-04 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, (P980016/S538) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,ADVISA SR MRI IPG (P980035/S423) | Medtronic, Inc. | 2015-05-04 |
| ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LEAD (P010015/S272) | Medtronic, Inc. | 2015-05-04 |
| ATTAIN ABILITY LEAD, ATTAIN PERFORMA LEAD, ATTAIN PERFORMA LEAD (P080006/S079) | Medtronic, Inc. | 2015-05-04 |
| ATTAIN STARFIX LEAD (P060039/S067) | Medtronic, Inc. | 2015-05-04 |
| CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,VITATRON CRYSTALLINE ACTIVE FIXATION LEADS (P930039/S129) | Medtronic, Inc. | 2015-05-04 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S268) | Medtronic, Inc. | 2015-05-04 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD (P850089/S114) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| CONSULTA CRT-D,MAXIMO II CRT-D, CONCERTO II CRT-D,CONCERTO CRT-D, PROTECTA AND PROTECTA XT,VIVA XT,VIVA S,BRAVA CRT-DS (P010031/S499) | Medtronic Cardiac Rhythm Disease Management | 2015-05-04 |
| SPRINT QUATTRO LEAD (P920015/S153) | Medtronic, Inc. | 2015-05-04 |
| TACTICATH QUARTZ SET (P130026/S004) | St Jude Medical | 2015-05-02 |
| MYOPORE SUTURELESS MYOCARDIAL PACING LEAD (P130012) | Great Batch Medical | 2015-04-30 |
| GORE CARDIOFORM SEPTAL OCCLUDER (P050006/S044) | W. L. Gore & Associates, Inc. | 2015-04-30 |
| TACTICATH QUARTZ SET (P130026/S003) | St Jude Medical | 2015-04-30 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM (P110023/S012) | Medtronic Vascular, Inc. | 2015-04-29 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S020) | LeMaitre Vascular, Inc. | 2015-04-29 |
| ATTAIN PERFORMA (P080006/S080) | Medtronic, Inc. | 2015-04-29 |
| ATTAIN PERFORMA (P080006/S078) | Medtronic, Inc. | 2015-04-28 |
| MODEL 5071 LEAD (P120017) | Medtronic, Inc. | 2015-04-27 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (P040044/S063) | Cordis US Corporation | 2015-04-24 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S023) | Corcym Canada Corp | 2015-04-23 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S112) | W. L. Gore & Associates, Inc. | 2015-04-23 |
| BLAZER II/ II HTD, BLAZER PRIME HTD SYSTEM CABLES (P920047/S078) | Boston Scientific Corp | 2015-04-23 |
| BLAZER II XP, BLAZER PRIME XP, INTELLATIP MIFI XP SYSTEM CABLES (P020025/S069) | Boston Scientific | 2015-04-23 |
| LIFESTENT VASCULAR STENT SYSTEM (P070014/S047) | Bard Peripheral Vascular, Inc. | 2015-04-23 |
| CHILLI II COOLED CATHETER ABLATION SYSTEM (P980003/S058) | Boston Scientific Corp | 2015-04-23 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BI (P860057/S136) | Edwards Lifesciences, LLC | 2015-04-23 |
| LUTONIX DRUG COATED BALLOON (DCB) (P130024/S004) | Lutonix | 2015-04-23 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S127) | Medtronic, Inc. | 2015-04-21 |
| ADVISA SR MRI (P980035/S418) | Medtronic, Inc. | 2015-04-21 |
| ADVISA SR MRI (P980035/S419) | Medtronic, Inc. | 2015-04-21 |
| CAPSUREFIX MRI LEAD (P090013/S182) | Medtronic, Inc. | 2015-04-21 |
| REVO MRI SURESCAN IPG (P090013/S183) | Medtronic, Inc. | 2015-04-21 |
| PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILY OF CRT-D DEVICES (P030054/S285) | ABBOTT MEDICAL | 2015-04-17 |
| CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES (P910023/S356) | ABBOTT MEDICAL | 2015-04-17 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S031) | Edwards Lifesciences, LLC | 2015-04-16 |
| CORDIS SMART CONTROL NITINOL STENT SYSTEMS (P020036/S032) | Cordis US Corporation | 2015-04-16 |
| CORDIS PALMAZ BALLOON-EXPANDABLE STENT (P890017/S016) | Cordis US Corporation | 2015-04-16 |
| PRECISE NITINOL STENT SYSTEMS (P030047/S028) | Cordis US Corporation | 2015-04-16 |
| INTRASTENT DOUBLESTRUT STENT (P030045/S002) | Medtronic Vascular, Inc. | 2015-04-16 |
| SMART CONTROL VASCULAR STENT SYSTEM (P120002/S008) | Cordis US Corporation | 2015-04-16 |
| CARPENTER-EDWARDS PERIMOUNT BIOPROSTHESIS HEART VALVE FAMILIES (P860057/S134) | Edwards Lifesciences, LLC | 2015-04-16 |
| CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P (P010015/S269) | Medtronic, Inc. | 2015-04-13 |
| SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S032) | Edwards Lifesciences, LLC | 2015-04-13 |
| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S417) | Medtronic, Inc. | 2015-04-13 |