| MATRIX VASCULAR CLOSURE SYSTEM (VSG) (P040044/S072) | Cordis US Corporation | 2016-05-04 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S022) | Cryolife, Inc. | 2016-05-04 |
| ADAPTA, VERSA, SENSIA IPG. ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG, ENOUKSE E2 IOG, KAPPA D IPG,KAPPA DR IP (P980035/S447) | Medtronic, Inc. | 2016-05-03 |
| EVERA MRI ICD, S DR ICD, S VR ICD, XT DR ICD, ST VR ICF, INTRINSIC 30 ICD, MARQUIS VR ICD, MAXIMO II ICD, PROTECT ICD, S (P980016/S562) | Medtronic Cardiac Rhythm Disease Management | 2016-05-03 |
| RENO MRI SURESCAN IPG (P090013/S209) | Medtronic, Inc. | 2016-05-03 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S365) | Boston Scientific | 2016-05-03 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S186) | Boston Scientific Corp | 2016-05-03 |
| CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S287) | Medtronic, Inc. | 2016-05-03 |
| CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005/S133) | Guidant Corp. | 2016-05-03 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE (P130013/S008) | Boston Scientific Corp | 2016-05-03 |
| MEDTRONIC MODEL 31301 CARELINK EXPRESS APP. (P890003/S345) | Medtronic, Inc. | 2016-05-03 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S411) | Boston Scientific Corp | 2016-05-03 |
| BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D; MAXIMO II CRT-D, PROTECTA CRT-D, PROTECT (P010031/S523) | Medtronic Cardiac Rhythm Disease Management | 2016-05-03 |
| IPERIA 7 HF-T (DR-1) & (DF-4); INVENTRA 7 HF-T (DF-1) & (DF-4) (P050023/S094) | Biotronik, Inc. | 2016-05-02 |
| Drug-Eluting Permanent Defibrillator Electrodes, Accessories to Implantable Pacemaker Pulse Generator (P980023/S074) | Biotronik, Inc. | 2016-05-02 |
| SETROX S 53, SAFIO S 53 (P950037/S161) | Biotronik, Inc. | 2016-05-02 |
| PROGRAMMER SOFTWARE (1507.U) FOR THE ICS 3000/RENAMIC PROGRAMMERS (P000009/S065) | Biotronik, Inc. | 2016-05-02 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S008) | ABBOTT MEDICAL | 2016-05-02 |
| COROX OTW 75 BP & 85 BP; COROX OTW-L 75 BP & 85 BP; COROX OTW-S 75 BP & 85 BP (P070008/S070) | Biotronik, Inc. | 2016-05-02 |
| Durata and Optisure HV leads (P950022/S092) | ABBOTT MEDICAL | 2016-05-01 |
| IsoFlex Optim LV leads (P960030/S044) | ABBOTT MEDICAL | 2016-05-01 |
| QuickFlex u and Quartet CRT leads (P030054/S303) | ABBOTT MEDICAL | 2016-05-01 |
| Tendril SDX, ST, STS and OptiSense LV leads (P960013/S081) | ABBOTT MEDICAL | 2016-05-01 |
| LIVEWIRE CARDIAC ABLATION SYSTEM (P960016/S056) | St Jude Medical | 2016-04-29 |
| ACUITY SPIRAL LEAD MODELS (P010012/S407) | Boston Scientific Corp | 2016-04-29 |
| CARDIOMEMS (P100045/S006) | ABBOTT MEDICAL | 2016-04-29 |
| THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETE, SAFIRE BLU ABLATION CATHETER, SAFIRE BLU SP (P060019/S033) | Irvine Biomedical, Inc. | 2016-04-29 |
| AMPLATZER SEPTAL OCCLUDER,CRIBRIFORM OCLUDER,AND DELIVERY AND EXCHANGE SYSTEMS (P000039/S052) | ABBOTT MEDICAL | 2016-04-29 |
| ANGIO-SEAL STS+,ANGIO-SEAL VIP, AND ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICES (P930038/S077) | Terumo Medical Corporation | 2016-04-29 |
| THERAPY DUAL 8 CATHETER,THERAPY 8MM THERMISTOR ABLATION CATHETER, SAFIRE TX, AND ASSOCIATED CABLES (P040042/S031) | Irvine Biomedical,Inc.(Ibi) | 2016-04-29 |
| THERAPY COOL PATH DUO ABLATION, THERAPY COOL PATH SP ABLATION CATHETER,SAFIRE BLU DUO ABLATION CATHETER,SAFIRE BLU DUO S (P110016/S021) | ABBOTT MEDICAL | 2016-04-29 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S223) | Medtronic, Inc. | 2016-04-29 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S543) | Medtronic Cardiac Rhythm Disease Management | 2016-04-29 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S581) | Medtronic Cardiac Rhythm Disease Management | 2016-04-29 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S297) | Medtronic, Inc. | 2016-04-29 |
| THERAPY CARDIAC ABLATION CATHETER (P040014/S026) | Irvine Biomedical, Inc. | 2016-04-29 |
| ENDOTAK RELIANCE IS-1 AND ENDOTAK RELIANCE 4-SITE LEAD MODELS (P910073/S133) | Boston Scientific | 2016-04-29 |
| MyCareLink Patient Monitor Model 24950 (P890003/S351) | Medtronic, Inc. | 2016-04-29 |
| AMPLATZER DUCT OCCLUDER AND DELIVERY AND EXCHANGE SYSTEMS (P020024/S041) | ABBOTT MEDICAL | 2016-04-29 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S460) | Medtronic, Inc. | 2016-04-29 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S024) | ABBOTT MEDICAL | 2016-04-29 |
| FINELINE II STEROX AND STEROX EZ LEADS (P960004/S075) | Boston Scientific | 2016-04-29 |
| PERCEVAL SUTURELESS HEART VALVE (P150011/S004) | Corcym S.r.l. | 2016-04-29 |
| THE HANCOCK VALVE CONDUIT LOW POROSITY (MODEL 150) (P870078/S031) | Medtronic, Inc. | 2016-04-28 |
| Tendril ST 1888/1882 TC; Tendril STS 2088 TC; Optisense 1999 (P960013/S080) | ABBOTT MEDICAL | 2016-04-28 |
| THE HANCOCK VALVED CONDUIT MODIFIED ORIFICE (MODEL 105) (P790007/S047) | Medtronic Heart Valves | 2016-04-28 |
| BLAZER PRIME HTD,BLAZER II,BLAZER II HTD TEMPERATURE ABLATION CATHETERS (P920047/S088) | Boston Scientific Corp | 2016-04-28 |
| VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX (P880086/S263) | ABBOTT MEDICAL | 2016-04-28 |
| CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 (P930039/S142) | Medtronic, Inc. | 2016-04-28 |
| ISOFLEX OPTIM (P960030/S040) | ABBOTT MEDICAL | 2016-04-28 |
| CareLink Programmer (Model 2090), Encore Programmer (Model 29901) (P890003/S350) | Medtronic, Inc. | 2016-04-28 |
| ADVISA MRI DR/SR SURESCAN IPGS AND PROGRAMMER SOFTWARE (P980035/S442) | Medtronic, Inc. | 2016-04-28 |
| ANTHEM, ALLURE, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF (P030035/S141) | ABBOTT MEDICAL | 2016-04-28 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S055) | ABBOTT MEDICAL | 2016-04-28 |
| DURATA, DURATA, OPTISURE (P950022/S089) | ABBOTT MEDICAL | 2016-04-28 |
| CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI (P090013/S205) | Medtronic, Inc. | 2016-04-28 |
| MICRONY (P970013/S067) | ABBOTT MEDICAL | 2016-04-28 |
| BLAZER PRIME XP,INTELLATIP MIFI XP, BLAZER II XP TEMPERATURE ABLATION CATHETERS (P020025/S082) | Boston Scientific | 2016-04-28 |
| CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE (P910023/S365) | ABBOTT MEDICAL | 2016-04-28 |
| TENDRIL SDX LEAD, TENDRIL ST LEAD, OPTISENSE, TENDRIL STS LEAD (P960013/S078) | ABBOTT MEDICAL | 2016-04-28 |
| EVERA MRI XT DR/VR SURESCAN,EVERA MRI S DR/VR SURESCAN ICDS AND PROGRAMMER SOFTWARE (P980016/S555) | Medtronic Cardiac Rhythm Disease Management | 2016-04-28 |
| IsoFlex 1944, 1948 (P960030/S043) | ABBOTT MEDICAL | 2016-04-28 |
| PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA, QUADRA ASSURA, QUICKFLEX U, QUARTET (P030054/S295) | ABBOTT MEDICAL | 2016-04-28 |
| SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935M,SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947M (P920015/S166) | Medtronic, Inc. | 2016-04-28 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S027) | Corcym Canada Corp | 2016-04-27 |
| SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S043) | Syncardia Systems, LLC | 2016-04-27 |
| ENDOTAK RELIANCE G/SG with 4-SITE Connector Defibrillation Leads, Passive Fixation Lead Models: 0265, 0266, 0282, 0283 (P910073/S134) | Boston Scientific | 2016-04-27 |
| FREEDOM SOLO STENTLESS HEART VALVE (P130011/S004) | Corcym Canada Corp | 2016-04-27 |
| XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM 13 (P070015/S132) | Abbott Vascular, Inc. | 2016-04-27 |
| XIENCE PRIME,XIENCE XPEDITION, XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S080) | Abbott Vascular | 2016-04-27 |
| BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S097) | ABBOTT MEDICAL | 2016-04-27 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S021) | Cryolife, Inc. | 2016-04-27 |
| PERCEVAL SUTURELESS HEART VALVE (P150011/S003) | Corcym S.r.l. | 2016-04-27 |
| BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT C (P010031/S546) | Medtronic Cardiac Rhythm Disease Management | 2016-04-26 |
| VISIA AF VR, VISIA AF MRI VR SURESCAN, EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, P (P980016/S585) | Medtronic Cardiac Rhythm Disease Management | 2016-04-26 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S011) | Bolton Medical, Inc. | 2016-04-26 |
| ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S021) | Spectranetics Corp. | 2016-04-26 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S002) | Bard Peripheral Vascular, Inc. | 2016-04-26 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S072) | Zoll Manufacturing Corporation | 2016-04-26 |
| CARELINK INSTRUMENT COMMAND LIBRARY, MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR. (P890003/S353) | Medtronic, Inc. | 2016-04-26 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012) | Boston Scientific | 2016-04-25 |
| BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P030031/S073) | Biosense Webster, Inc. | 2016-04-25 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S080) | Terumo Medical Corporation | 2016-04-25 |
| NAVISTAR DS CATHETER, EZ Steer Nav DS Bi-Directional Catheter (P010068/S050) | Biosense Webster, Inc. | 2016-04-25 |
| THERMOCOOL SMART TOUCH UNI-DIRECTIONAL NAVIGATION CATHETER (P040036/S054) | Biosense Webster, Inc. | 2016-04-25 |
| EZ Steer DS Bi-Directional Catheter,EZ Steer Bi-Directional CatheterABLATION, Celsius Flutter Bi-Directional Catheter (P950005/S060) | Biosense Webster, Inc. | 2016-04-25 |
| NAVI-STAR and EZ Steer Nav Bi-Directional Catheter (P990025/S048) | Biosense Webster, Inc. | 2016-04-25 |
| TRIFECTA VALVE WITH GLIDE TECHNOLOGY (P100029/S021) | ABBOTT MEDICAL | 2016-04-24 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S533) | Medtronic Cardiac Rhythm Disease Management | 2016-04-22 |
| Verity 5056, 5156, 5256, 5356, 5456, 5816; Zephyr 5826, 5626; Identity 5286, 5386; Sustain XL PM1134, PM1136, PM2134, PM (P880086/S271) | ABBOTT MEDICAL | 2016-04-22 |
| Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ (P010031/S544) | Medtronic Cardiac Rhythm Disease Management | 2016-04-22 |
| VALIANT THORACIC STENT GRAFT WITH CAPTIVA DELIVERY SYSTEM (P100040/S025) | Medtronic Vascular | 2016-04-22 |
| Revo MRI SureScan IPG RVDR01 (P090013/S224) | Medtronic, Inc. | 2016-04-22 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S044) | Medtronic Vascular | 2016-04-22 |
| Adapta, Versa, Sensia IPG ADDR01, ADDRL1, ADDRS1, SEDR01, SESR01, VEDR01, ADD01, SEDRL1, SED01, SES01, ADSR01, ADVDD01; (P980035/S461) | Medtronic, Inc. | 2016-04-22 |
| Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01 (P010015/S298) | Medtronic, Inc. | 2016-04-22 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S084) | W. L. Gore & Associates, Inc. | 2016-04-22 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S572) | Medtronic Cardiac Rhythm Disease Management | 2016-04-22 |
| Evera MRI ICD DDMB1D4, DDMC3D4; Evera S DR ICD DDBC3D1, DDBC3D4; Evera S VR ICD DVBC3D1; Evera XT DR ICD DDBB1D1, DDBB1D (P980016/S583) | Medtronic Cardiac Rhythm Disease Management | 2016-04-22 |
| ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER (P980037/S057) | Boston Scientific Corp | 2016-04-22 |