| INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S001) | Boston Scientific Corporation | 2015-09-21 |
| ANGIOJET ULTRA XMI THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY (P980037/S048) | Boston Scientific Corp | 2015-09-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S121) | W. L. Gore & Associates, Inc. | 2015-09-21 |
| INTEGRITY CORONARY STENT SYSTEM (P030009/S082) | Medtronic, Ireland | 2015-09-18 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S055) | Medtronic Vascular | 2015-09-18 |
| TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN EL. DYNAGEN MINI, INOGEN EL, INOGEN MINI, ORIGEN EL, ORIGEN MINI ICD'S (P960040/S351) | Boston Scientific | 2015-09-17 |
| ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE (P980037/S047) | Boston Scientific Corp | 2015-09-17 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S056) | Medtronic Vascular | 2015-09-17 |
| COGNIS, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4, CRT-D (P010012/S395) | Boston Scientific Corp | 2015-09-17 |
| STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR (P990071/S032) | Biosense Webster, Inc. | 2015-09-16 |
| ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS (P880086/S258) | ABBOTT MEDICAL | 2015-09-16 |
| PROMOTE/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA, EPIC+/HF/HF+/II HF/II+H (P030054/S287) | ABBOTT MEDICAL | 2015-09-16 |
| SMARTVIEW REMOTE MONITORING SYSTEM (P980049/S105) | MicroPort CRM USA, Inc. | 2015-09-16 |
| SMARTVIEW REMOTE MONITORING SYSTEM (P060027/S072) | MicroPort CRM USA, Inc. | 2015-09-16 |
| ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-PS (P030035/S136) | ABBOTT MEDICAL | 2015-09-16 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S102) | MicroPort CRM USA, Inc. | 2015-09-16 |
| CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICDS (P910023/S358) | ABBOTT MEDICAL | 2015-09-16 |
| EPT-1000XP CARDIAC ABLATION SYSTEM (P020025/S078) | Boston Scientific | 2015-09-15 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S084) | Boston Scientific Corp | 2015-09-15 |
| ON-X PROSTHETIC HEART VALVE (P000037/S040) | On-X Life Technologies, Inc. | 2015-09-15 |
| CHILLI II COOLED ABLATION SYSTEM (P980003/S063) | Boston Scientific Corp | 2015-09-15 |
| ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT (P140016) | Cook Medical Incorporated | 2015-09-15 |
| FLEXABILITY ABLATION CATHETERS (UNI-DIRECTIONAL),FLEXABILITY ABLATION CATHETERS (BI-DIRECTIONAL) (P110016/S022) | ABBOTT MEDICAL | 2015-09-14 |
| EVERA MRI XT DR, XT VR, S DR, S VR SURESCAN ICD'S (P980016/S536) | Medtronic Cardiac Rhythm Disease Management | 2015-09-11 |
| 5086 MRI CAPSUREFIX MRI SURESCAN LEADS (P090013/S200) | Medtronic, Inc. | 2015-09-11 |
| VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM (P100040/S024) | Medtronic Vascular | 2015-09-11 |
| 5076 CAPSUREFIX NOVUS SURESCAN LEADS (P930039/S138) | Medtronic, Inc. | 2015-09-11 |
| SPRINT QUATTRO SECURE S MRI SURESCAN AND SPRINT QUATTRO SECURE MRI SURESCAN (P920015/S151) | Medtronic, Inc. | 2015-09-11 |
| CARELINK MONITOR AND EXPRESS MONITOR, CARDIOSIGHT READER; CARELINK EXPRESS (P890003/S329) | Medtronic, Inc. | 2015-09-11 |
| ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM, ENDURANT II'S STENT GRAFT SYSTEM (P100021/S049) | Medtronic Vascular | 2015-09-11 |
| GORE CONFORMABLE TAG THORACIC ENDOPROSTHESIS (P040043/S077) | W. L. Gore & Associates, Inc. | 2015-09-10 |
| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S436) | Medtronic, Inc. | 2015-09-10 |
| CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S360) | ABBOTT MEDICAL | 2015-09-10 |
| REVO MRI SURESCAN IPG (P090013/S197) | Medtronic, Inc. | 2015-09-10 |
| PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILES OF CRT-D DEVICES (P030054/S289) | ABBOTT MEDICAL | 2015-09-10 |
| CONSULTA CRT-P, SYNCRA CRT-P. VIVA CRT-P (P010015/S278) | Medtronic, Inc. | 2015-09-10 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S277) | Medtronic, Inc. | 2015-09-09 |
| 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/S509) | Medtronic Cardiac Rhythm Disease Management | 2015-09-09 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S009) | Medtronic, Ireland | 2015-09-09 |
| EVERA S DR .S VR, XT DR, XT VR ICD'S, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S546) | Medtronic Cardiac Rhythm Disease Management | 2015-09-09 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, RELIA IPG (P980035/S435) | Medtronic, Inc. | 2015-09-09 |
| REVO MRI SURESCAN IPG (P090013/S196) | Medtronic, Inc. | 2015-09-09 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S007) | Lutonix | 2015-09-04 |
| CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS (P040043/S076) | W. L. Gore & Associates, Inc. | 2015-09-04 |
| ANTHEM, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF FAMILY OF CRT-P DEVICES (P030035/S137) | ABBOTT MEDICAL | 2015-09-03 |
| TACTICATH QUARTZ ABLATION CATHETER (P130026/S008) | St Jude Medical | 2015-09-03 |
| ISOFLEX OPTIM FAMILY OF PACING LEADS (P960030/S039) | ABBOTT MEDICAL | 2015-09-03 |
| CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES; MERLIN.NET SYSTEM AND MERLIN@HOME (P910023/S359) | ABBOTT MEDICAL | 2015-09-03 |
| WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE TECHNOLOGY (P130013/S003) | Boston Scientific Corp | 2015-09-03 |
| NIRXCELL COCR CORONARY STENT ON RX SYSTEM (P110004/S012) | Medinol, Ltd. | 2015-09-03 |
| TENDRIL SDX, TENDRIL ST, OPTISENSE, TENDRIL STS FAMILY OF LV LEADS (P960013/S077) | ABBOTT MEDICAL | 2015-09-03 |
| PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S115) | Boston Scientific Corp | 2015-09-03 |
| PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILY OF CRT-D DEVICES; MERLIN PROGRAMMER (P030054/S288) | ABBOTT MEDICAL | 2015-09-03 |
| VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKER DEVICES (P880086/S259) | ABBOTT MEDICAL | 2015-09-03 |
| MICRONY PACEMAKER (P970013/S065) | ABBOTT MEDICAL | 2015-09-03 |
| DURATA, OPTISURE FAMILY OF HV LEADS (P950022/S088) | ABBOTT MEDICAL | 2015-09-03 |
| ASCENDRA+ DELIVERY SYSTEM (P130009/S038) | Edwards Lifesciences, LLC | 2015-09-02 |
| RF CONTACTR, RF ENHANCR II, RF MARINR, RF CONDUCTR. (P930029/S053) | Medtronic, Inc. | 2015-09-02 |
| THERAPY COOL FLEX AND FLEXABILITY ABLATION CATHETERS (P110016/S020) | ABBOTT MEDICAL | 2015-09-02 |
| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S434) | Medtronic, Inc. | 2015-09-02 |
| REBEL MONORAIL AND OVER THE WIRE PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S016) | Boston Scientific Corp | 2015-09-02 |
| EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S069) | Boston Scientific Corp | 2015-09-02 |
| WATCHMAN LAA CLOSURE TECHNOLOGY (P130013/S005) | Boston Scientific Corp | 2015-09-02 |
| GORE CARDIOFORM SEPTAL OCCLUDER (P050006/S048) | W. L. Gore & Associates, Inc. | 2015-09-01 |
| AORFIX AN AAA FLEXIBLE STENT GRAFT SYSTEM (P110032/S011) | Lombard Medical Limited | 2015-09-01 |
| SETROX S 45, SETROX S 53, SETROX S 60, DEXTRUS 4135, DEXTRUS 4136, DEXTRUS 4137, SAFIO S 53, SAFIO S 60, TILDA JT45, TIL (P950037/S158) | Biotronik, Inc. | 2015-08-31 |
| LIVEWIRE TC ABLATION CATHETER (P960016/S055) | St Jude Medical | 2015-08-31 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S054) | Corcym S.r.l. | 2015-08-31 |
| COROX OTW 75-BP, COROX OTW 85-BP, COROX OTW-S 75-BP, COROX OTW-S 85-BP, COROX OTW-L 85-BP, COROX OTW-L 75-BP, CELERITY 2 (P070008/S068) | Biotronik, Inc. | 2015-08-31 |
| ZILVER VASCULAR STENT (P050017/S012) | Cook Ireland, Ltd. | 2015-08-31 |
| LINOX SMART SD 60/16, LINOX SMART SD 65/16, LINOX SMART SD 65/18, LINOX SMART SD 75/18, LINOX SMART TD 65/16, LINOX SMAR (P980023/S073) | Biotronik, Inc. | 2015-08-31 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S064) | ABBOTT MEDICAL | 2015-08-27 |
| EN VEO R DELIVERY SYSTEM (DCS)COMPONENT OF CORE VALUE EVOLUT R SYSTEM (P130021/S017) | Medtronic, Inc. | 2015-08-27 |
| AFFINITY/INTEGRITY / VICTORY /ZEPHYR ACCENT FAMILY OF PACEMAKERS (P880086/S255) | ABBOTT MEDICAL | 2015-08-27 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S (P910023/S355) | ABBOTT MEDICAL | 2015-08-27 |
| FRONTIER / FRONTIER II / ANTHEM FAMILY OF CRT-P'S (P030035/S133) | ABBOTT MEDICAL | 2015-08-27 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S065) | Medtronic | 2015-08-27 |
| SENSOLOG / DIALOG/ REGENCY FAMILY OF PACEMAKERS (P880006/S093) | St. Jude Medical, Inc. | 2015-08-27 |
| QUADRA ASSURA / UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S284) | ABBOTT MEDICAL | 2015-08-27 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S003) | AtriCure, Inc. | 2015-08-26 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S065) | Zoll Manufacturing Corporation | 2015-08-22 |
| DYNAGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4CRT-D, ORIGEN CRT-D, X4 CRT-D, INCEPTA TM ICD, ENERGEN TM ICD & PUNCTUA TM ICD (P010012/S397) | Boston Scientific Corp | 2015-08-21 |
| GENE2.0 S-ICD: A209 (P110042/S049) | Boston Scientific Corporation | 2015-08-21 |
| ORIGEN EL ICD, MINI ICD, DYNAGEN EL ICD, MINI ICD, INOGEN EL ICD, MINI ICD, INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD (P960040/S353) | Boston Scientific | 2015-08-21 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (P060040/S043) | ABBOTT MEDICAL | 2015-08-20 |
| EVERA S DR,SVR, XT DR.XT VR ICD'S; MAXIMO II ICD, PROTECTA ICD & XT ICD; SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S543) | Medtronic Cardiac Rhythm Disease Management | 2015-08-20 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S150) | Boston Scientific Corp | 2015-08-20 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S043) | Medtronic Vascular | 2015-08-20 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S012) | Cordis US Corporation | 2015-08-20 |
| VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM (P100040/S023) | Medtronic Vascular | 2015-08-20 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA CRT-D, VIVA (P010031/S507) | Medtronic Cardiac Rhythm Disease Management | 2015-08-20 |
| TACTICATH QUARTZ SET (P130026/S006) | St Jude Medical | 2015-08-20 |
| INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER (P020025/S075) | Boston Scientific | 2015-08-19 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S062) | Boston Scientific Corp | 2015-08-19 |
| EVERA S DR ICD, S VR ICD; EVERA XT DR ICD, XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PRO (P980016/S542) | Medtronic Cardiac Rhythm Disease Management | 2015-08-19 |
| 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, VIV (P010031/S506) | Medtronic Cardiac Rhythm Disease Management | 2015-08-19 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S054) | Medtronic Vascular | 2015-08-19 |
| REVO MRI SURESCAN IPG (P090013/S195) | Medtronic, Inc. | 2015-08-18 |
| FINELINE II STEROID-ELUTING PACING LEADS, PASSIVE AND ACTIVE FIXATIONS MODELS (P960004/S072) | Boston Scientific | 2015-08-18 |
| THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P030031/S070) | Biosense Webster, Inc. | 2015-08-18 |