| Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1, DVBC3D4; Ever (P980016/S566) | Medtronic Cardiac Rhythm Disease Management | 2016-02-29 |
| Revo MRI SureScan IPG RVDR01 (P090013/S217) | Medtronic, Inc. | 2016-02-29 |
| Advisa DR IPG A4DR01; Advisa DR MRI IPG A2DR01; Advisa SR MRI IPG A3SR01 (P980035/S455) | Medtronic, Inc. | 2016-02-29 |
| THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER (P040042/S034) | Irvine Biomedical,Inc.(Ibi) | 2016-02-29 |
| IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR (P040014/S029) | Irvine Biomedical, Inc. | 2016-02-29 |
| GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS (P020004/S123) | W. L. Gore & Associates, Inc. | 2016-02-29 |
| Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Viva Quad S CRT-D DTBB1Q1, DTBB1QQ, Viva Quad XT CRT-D (P010031/S527) | Medtronic Cardiac Rhythm Disease Management | 2016-02-29 |
| Consulta CRT-P C4TR01; Syncra CRT-P C2TR01 (P010015/S292) | Medtronic, Inc. | 2016-02-29 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S029) | ABBOTT MEDICAL | 2016-02-29 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S119) | Boston Scientific Corp | 2016-02-26 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P130030/S020) | Boston Scientific Corp | 2016-02-26 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S071) | Boston Scientific Corp | 2016-02-26 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S125) | W. L. Gore & Associates, Inc. | 2016-02-26 |
| D-STAT FLOWABLE HEMOSTAT (P990037/S032) | Vascular Solutions, Inc. | 2016-02-25 |
| COMPLETE SE VASCULAR STENT SYSTEM (P110040/S007) | Medtronic Vascular | 2016-02-25 |
| LIVEWIRE TC ABLATION CATHETER, SAFIRE ABLATION CATHETER (P960016/S059) | St Jude Medical | 2016-02-24 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S053) | ABBOTT MEDICAL | 2016-02-24 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005) | Boston Scientific Corp | 2016-02-24 |
| PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S102) | Boston Scientific Corp | 2016-02-24 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S025) | ABBOTT MEDICAL | 2016-02-24 |
| INTELLANAV XP TEMPERATURE ABLATION CATHETER, INTELLANAV MIFI XP TEMPERATURE ABLATION CATHETER, INTELLANAV ABLATION CATHE (P020025/S077) | Boston Scientific | 2016-02-24 |
| AMPLATZER DUCT OCCLUDER, AMPLATZER DUCT OCCLUDER II, (P020024/S042) | ABBOTT MEDICAL | 2016-02-24 |
| FLEXABILITY ABLATION CATHETER (P110016/S024) | ABBOTT MEDICAL | 2016-02-24 |
| TACTICATH QUARTZ ABLATION CATHETER (P130026/S011) | St Jude Medical | 2016-02-24 |
| PERCEVAL SUTURELESS HEART VALVE (P150011/S001) | Corcym S.r.l. | 2016-02-24 |
| THERAPY COOL PATH ABLATION CATHETER AND IBI-1500T9 RF ABLATION GENERATOR (P060019/S032) | Irvine Biomedical, Inc. | 2016-02-24 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S051) | ABBOTT MEDICAL | 2016-02-24 |
| ACUITY X4 STRAIGHT (4671,4672), SPIRAL S (4674,4675), SPIRAL L (4677,4678) LEADS; SUTURELESS SLEEVE & FLUSHING TOOL/WIRE (P010012/S398) | Boston Scientific Corp | 2016-02-22 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS), THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P060040/S048) | ABBOTT MEDICAL | 2016-02-22 |
| EDWARDS COMMANDER DELIVERY SYSTEM (P140031/S007) | Edwards Lifesciences, LLC | 2016-02-22 |
| RELIANCE 4-SITE LEAD FAMILY (P910073/S132) | Boston Scientific | 2016-02-22 |
| EVERA MRI, EVERA, MARQUIS, SECURA, MAXIMO II, INTRINSIC, PROTECTA, PROTECTA XT, VIRTUOSO II (P980016/S563) | Medtronic Cardiac Rhythm Disease Management | 2016-02-22 |
| Ellipse DR Models CD2311-36, CD2311-36Q, CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC; Ellipse VR Models CD1311-36, CD (P910023/S369) | ABBOTT MEDICAL | 2016-02-22 |
| ADAPTA, VERSA, SENSIA, ADVISA, ADVISA MRI,ENPULSE, KAPPA (P980035/S450) | Medtronic, Inc. | 2016-02-22 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S288) | Medtronic, Inc. | 2016-02-22 |
| Victory Models 5816, 5810, 5610; Zephyr Models 5820, 5826, 5620, 5626; Accent Models PM1110, PM1210, PM2110, PM2210; As (P880086/S269) | ABBOTT MEDICAL | 2016-02-22 |
| MYCARE LINK PATIENT MONITOR (P890003/S346) | Medtronic, Inc. | 2016-02-22 |
| REVO MRI (P090013/S211) | Medtronic, Inc. | 2016-02-22 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S038) | Syncardia Systems, LLC | 2016-02-22 |
| VIVA, BRAVA, PROTECTA, PROTECTA XT, CONCERTO, CONCERTO II, CONSULTA, MAXIMO II, INSYNC II PROTECT (P010031/S524) | Medtronic Cardiac Rhythm Disease Management | 2016-02-22 |
| Assurity Models PM1240, PM2240; Assurity+ Models PM1260, PM2260; Endurity Models PM1160, PM2160; Endurity Core Models CD (P880086/S270) | ABBOTT MEDICAL | 2016-02-22 |
| TACTICATH QUARTZ SET (P130026/S015) | St Jude Medical | 2016-02-19 |
| THERAPY ABLATION CATHETERS (P040014/S028) | Irvine Biomedical, Inc. | 2016-02-18 |
| THERAPY DUAL 8, THERAPY 8MM THERMISTOR, AND SAFIRE TX ABLATION CATHETERS, AND 1500T6 AND 1500T9 RF GENERATOR (P040042/S033) | Irvine Biomedical,Inc.(Ibi) | 2016-02-18 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S089) | W. L. Gore & Associates, Inc. | 2016-02-18 |
| THERAPY COOL PATH DUO,SAFIRE BLU DUO AND COOL PATH DUO,THERAPY COOL PATH DUO SP,SAFIRE BLU DUO SP,THERAY COOL FLEX CATHP (P110016/S027) | ABBOTT MEDICAL | 2016-02-18 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S028) | W. L. Gore & Associates, Inc. | 2016-02-18 |
| THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS) (P060040/S050) | ABBOTT MEDICAL | 2016-02-18 |
| LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER (P960016/S060) | St Jude Medical | 2016-02-18 |
| TACTICATH QUARTZ SET (P130026/S012) | St Jude Medical | 2016-02-18 |
| THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP AND THERAPY COOL PATH SP ABLATION CATHETERS, AND 1500T9-CP RF GENERATORS (P060019/S035) | Irvine Biomedical, Inc. | 2016-02-18 |
| DURATA AND OPTISURE HV LEADS (P950022/S091) | ABBOTT MEDICAL | 2016-02-17 |
| TENDRIL SDX, ST, STS, AND OPTISCIENSE L V LEADS (P960013/S079) | ABBOTT MEDICAL | 2016-02-17 |
| QUICKFLEX U AND QUARTET CRT LEADS (P030054/S298) | ABBOTT MEDICAL | 2016-02-17 |
| IsoFlex Models 1642T, 1646T, 1944, 1948 (P960030/S042) | ABBOTT MEDICAL | 2016-02-17 |
| ISOFLEX OPTIM LV LEADS (P960030/S041) | ABBOTT MEDICAL | 2016-02-17 |
| QuickFlex u Model 1258T (P030054/S299) | ABBOTT MEDICAL | 2016-02-17 |
| EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S046) | Edwards Lifesciences, LLC | 2016-02-16 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S048) | Edwards Lifesciences, LLC | 2016-02-16 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S047) | Edwards Lifesciences, LLC | 2016-02-16 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIMUM CORONARY STENT SYSTEM PROMUS PREMIER EVEROLIMUS-ELUTING PLATIN (P110010/S116) | Boston Scientific Corp | 2016-02-16 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S008) | Edwards Lifesciences, LLC | 2016-02-16 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S123) | Boston Scientific Corp | 2016-02-16 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S017) | Boston Scientific Corp | 2016-02-16 |
| OPEN PIVOT HEART VALVE, OPEN PIVOT AORTIC VALVED GRAFT, OPEN PIVOT HEART VALVE-APEX, OPEN PIVOT HEART VALVE-AP360 (P990046/S042) | Medtronic Ats Medical, Inc. | 2016-02-12 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S094) | St. Jude Medical, Inc. | 2016-02-12 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S138) | ABBOTT MEDICAL | 2016-02-12 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S066) | ABBOTT MEDICAL | 2016-02-12 |
| ANGIOJET ULTRA THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY, ANGIOJ (P980037/S056) | Boston Scientific Corp | 2016-02-12 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S291) | ABBOTT MEDICAL | 2016-02-12 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S260) | ABBOTT MEDICAL | 2016-02-12 |
| ATTAIN ABILITY LEAD Models 4196, 4296, 4396 (P080006/S088) | Medtronic, Inc. | 2016-02-12 |
| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM (P910001/S083) | Spectranetics Corp. | 2016-02-12 |
| CLOSER VASCULAR SEALING SYSTEM (P150022) | Rex Medical, L.P. | 2016-02-12 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S018) | Boston Scientific Corp | 2016-02-12 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S (P910023/S361) | ABBOTT MEDICAL | 2016-02-12 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, RELIA IPG (P980035/S453) | Medtronic, Inc. | 2016-02-11 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S081) | W. L. Gore & Associates, Inc. | 2016-02-11 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (P130009/S045) | Edwards Lifesciences, LLC | 2016-02-10 |
| EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S006) | Edwards Lifesciences, LLC | 2016-02-10 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016/S019) | Cardiva Medical, Inc. | 2016-02-10 |
| ANGIOJET ULTRA XMI THROMBECTOMY SET; ANGIOJET ULTRA SPIROFLEX & SPIROFLEX VG THROMBECTOMY SET; ANGIOLET ULTRA DISTAFLEX (P980037/S055) | Boston Scientific Corp | 2016-02-10 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS. RSR PERICARDIAL AORTIC BIOPROSTHESIS, MAGNA PERICARDIAL A (P860057/S141) | Edwards Lifesciences, LLC | 2016-02-10 |
| SOLO SMART STENTLESS HEART VALVE (SOLO SMART) (P130011/S002) | Corcym Canada Corp | 2016-02-09 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S070) | Zoll Manufacturing Corporation | 2016-02-09 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S070) | Medtronic | 2016-02-09 |
| SPRINT QUATTRO LEAD ; SPRINT QUATTRO LEAD (P920015/S173) | Medtronic, Inc. | 2016-02-09 |
| CHILLI II COOLED ABLATION SYSTEM (P920047/S083) | Boston Scientific Corp | 2016-02-08 |
| CHILLI II COOLED ABLATION SYSTEM (P020025/S076) | Boston Scientific | 2016-02-08 |
| OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT (P990046/S041) | Medtronic Ats Medical, Inc. | 2016-02-08 |
| PROMOTE+UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILY OF CRT-D DIVICES (P030054/S297) | ABBOTT MEDICAL | 2016-02-08 |
| CHILLI II COOLED ABLATION SYSTEM (P980003/S061) | Boston Scientific Corp | 2016-02-08 |
| CURRENT+ FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES (P910023/S367) | ABBOTT MEDICAL | 2016-02-08 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S049) | W. L. Gore & Associates, Inc. | 2016-02-08 |
| INVIVE, INTUA, VISIONIST, VALITUDE CRT-P RESYNCHRONIZATION DEVICES (P030005/S131) | Guidant Corp. | 2016-02-05 |
| EVERA S DR,S VR XT DR, XT VE,ICD'S; MAXIMO II ICD,. PROTECTA ICD & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S561) | Medtronic Cardiac Rhythm Disease Management | 2016-02-05 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN ICD DEVICES (P960040/S362) | Boston Scientific | 2016-02-05 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, CRT-D RESYNCHRONIZATION DEVICES (P010012/S408) | Boston Scientific Corp | 2016-02-05 |
| ADVANTIO, INGENIO, VITALIO, FORMIO ESSENTIO, ACCOLADE, PROPONENT, AND ALTRUA 2 SUPPORTED BY LATITUDE CONSULT ONLY) (PACE (N970003/S184) | Boston Scientific Corp | 2016-02-05 |
| LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460 (P910077/S151) | Boston Scientific | 2016-02-05 |