| THERAPY ABLATION CATHETERS (P040014/S027) | Irvine Biomedical, Inc. | 2015-10-21 |
| PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNHRONIZATION THERAPY-DEFIBRILLATOR (P010012/S402) | Boston Scientific Corp | 2015-10-21 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S050) | Medtronic, Inc. | 2015-10-21 |
| PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P960040/S357) | Boston Scientific | 2015-10-21 |
| THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS (P040042/S032) | Irvine Biomedical,Inc.(Ibi) | 2015-10-21 |
| CVX-300/CVX300-P EXCIMER LASER SYSTEM (P910001/S078) | Spectranetics Corp. | 2015-10-20 |
| COMPLETE SE VASCULAR STENT SYSTEM- ILIAC (P090006/S016) | Medtronic Vascular | 2015-10-20 |
| COMPLETE SE VASCULAR STENT SYSTEM- SFA AND PPA (P110040/S008) | Medtronic Vascular | 2015-10-20 |
| LEGEND PLUS IPG (P930022/S017) | Medtronic, Inc. | 2015-10-19 |
| VITATRON C20 SR IPG,VITATRON C60 DR IPG,VITATRON T20 SR IPG,VITATRON T60 DR IPG (P990001/S119) | Medtronic, Inc. | 2015-10-19 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; EDWARDS QUALCRIMP CRIMPING ACCESSORY (P130009/S004) | Edwards Lifesciences, LLC | 2015-10-19 |
| BRAVA,BRAVA QUAD,CONCERTO II,CONSULTA,MAXIMO II,PROTECTA,PROTECTA XT,VIVA QUAD S, VIVA QUAD XT,VIVA S, VIVA XT CRT-DS, C (P010031/S478) | Medtronic Cardiac Rhythm Disease Management | 2015-10-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S042) | Edwards Lifesciences, LLC | 2015-10-19 |
| CARPENTIER-EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS, THEON PERICARDIAL AOTIC BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS (P860057/S127) | Edwards Lifesciences, LLC | 2015-10-19 |
| ORIGEN EL ICD & MINI ICD, INOGEN EL ICD & MINI ICD; DYNAGEN EL ICD & MINI ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S356) | Boston Scientific | 2015-10-19 |
| KAPPA 400 DR IPG,KAPPA 400 SR IPG (P970012/S096) | Medtronic, Inc. | 2015-10-19 |
| JEWEL AF ICD (P980050/S097) | Medtronic, Inc. | 2015-10-19 |
| SYMBIOS,SYNERGYST IPGS (P820003/S132) | Medtronic Cardiac Rhythm Disease Management | 2015-10-19 |
| REVO MRI IPG (P090013/S165) | Medtronic, Inc. | 2015-10-19 |
| MEDTRONIC GEM ICD,MEDTRONIC JEWEL ICD,MEDTRONIC JEWEL PLUS ICD,MEDTRONIC MICRO JEWEL ICD,MEDTRONIC MICRO JEWEL II ICD,ME (P900061/S133) | Medtronic Cardiac Rhythm Disease Management | 2015-10-19 |
| EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD,GEM DR ICD,GEM II DR ICD, GEM II VR ICD,GEM III VR ICD,I (P980016/S514) | Medtronic Cardiac Rhythm Disease Management | 2015-10-19 |
| ELITE,ELITE II,MINUET,PREVA,PRODIGY,THERA D,THERA DR IPGS, THERA ID PG,THERA IPG,THERA S IPG,THERA SR IPG,THERA VDD IPG, (P890003/S326) | Medtronic, Inc. | 2015-10-19 |
| ACTIVITRAX II IPG,ACTIVITRAX IPG,LEGEND II IPG,LEGEND IPG,MICRO MINIX IPG,MINIX IPG,MINIX ST IPG,PREMIER IPG,PREVAIL IPG (P850051/S082) | Medtronic, Inc. | 2015-10-19 |
| EMBLEM S-ICD PULSE GENERATOR (P110042/S051) | Boston Scientific Corporation | 2015-10-19 |
| MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM (P920015/S146) | Medtronic, Inc. | 2015-10-19 |
| HEARTMATE II LVAS SYSTEM (P060040/S046) | ABBOTT MEDICAL | 2015-10-19 |
| CONSULTA,SYNCRA,VIVA CRT-PS,INSYNC IPG (P010015/S255) | Medtronic, Inc. | 2015-10-19 |
| EDWARDS SAPIEN TRANSCATHER HEART VALVE (P100041/S055) | Edwards Lifesciences, LLC | 2015-10-19 |
| ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,AT500 DDDRP PACING SYSTEM IPG, ENPULSE E2 IPG,ENPULSE E2 IPG,KAP (P980035/S404) | Medtronic, Inc. | 2015-10-19 |
| ORIGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4 CRT-D; DYNAGEN CRT-D, X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS (P010012/S401) | Boston Scientific Corp | 2015-10-19 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S045) | Medtronic Vascular | 2015-10-15 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S013) | ABBOTT MEDICAL | 2015-10-15 |
| IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S010) | Medtronic, Inc. | 2015-10-15 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S044) | ABBOTT MEDICAL | 2015-10-14 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S081) | W. L. Gore & Associates, Inc. | 2015-10-14 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S020) | W. L. Gore & Associates, Inc. | 2015-10-14 |
| EVERA MRI XT DR SURESCAN ICD, EVERA MRI XT VR SURESCAN ICD,EVERA MRI S DR SURESCAN ICD, EVERA MRI S VR SURESCAN ICD (P980016/S549) | Medtronic Cardiac Rhythm Disease Management | 2015-10-14 |
| FINELINE II STEROX IMPLANTABLE CARDIAC ENDOCARDIAL PACING LEADS (P960004/S074) | Boston Scientific | 2015-10-13 |
| ROTABLATOR ROTATIONAL ANGOPLASTY SYSTEM GUIDEWIRE (P900056/S151) | Boston Scientific Corp | 2015-10-13 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S064) | Boston Scientific Corp | 2015-10-13 |
| 3F AORTIC BIOPROSTHESIS (P060025/S014) | Medtronic, Inc. | 2015-10-13 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S080) | Boston Scientific | 2015-10-13 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S086) | Boston Scientific Corp | 2015-10-13 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S025) | Corcym Canada Corp | 2015-10-12 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S034) | Edwards Lifesciences, LLC | 2015-10-09 |
| PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE DEVICE (P960043/S090) | Abbott Vascular, Inc. | 2015-10-09 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S033) | Abbott Vascular Devices | 2015-10-09 |
| FINELINE II STEROX AND STEROX EZ ENDOCARDIAL PACING LEAD (P960004/S059) | Boston Scientific | 2015-10-08 |
| ADVISA, ENRHYTHM MRI (P980035/S437) | Medtronic, Inc. | 2015-10-07 |
| ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, SECURA, VIRTUOSO II. INSYNC MARQUIS, PROTECTA/ PROTECTA XT DR (P980016/S547) | Medtronic Cardiac Rhythm Disease Management | 2015-10-07 |
| CARELINK PATIENT MONITOR 2490G, CARDIOSIGHT READER, CARELINK EXPRESS, REVEAL DX/XT, REVEAL LINQ INSERTABLE CARDIAC MONIT (P890003/S336) | Medtronic, Inc. | 2015-10-07 |
| CAPSUREFIX MRI LEAD (P090013/S201) | Medtronic, Inc. | 2015-10-07 |
| INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD, DYNAGEN ICD, INOGEN ICD, ORIGEN ICD (P960040/S355) | Boston Scientific | 2015-10-07 |
| EMBLEM SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S ICD ) (P110042/S050) | Boston Scientific Corporation | 2015-10-07 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S279) | Medtronic, Inc. | 2015-10-07 |
| CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S139) | Medtronic, Inc. | 2015-10-07 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S055) | Endologix, LLC | 2015-10-07 |
| REVO MRI (P090013/S198) | Medtronic, Inc. | 2015-10-07 |
| VENASEAL CLOSURE SYSTEM (P140018/S001) | Medtronic Vascular, Inc. | 2015-10-07 |
| INCEPTA CRT D, ENERGEN CRT D, PUNCTUA CRT-D, DYNAGEN CRT-D, INOGEN CRT D, ORIGEN CRT-D (P010012/S400) | Boston Scientific Corp | 2015-10-07 |
| PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S293) | ABBOTT MEDICAL | 2015-10-07 |
| MAXIMO II CRT-D, CONCERTO, CONCERTO II, CONSULTA, INSYNC II MARQUIS, INSYNC III MARQUIS, INSYNC MAXIMO, INSYNC SENTRY, (P010031/S510) | Medtronic Cardiac Rhythm Disease Management | 2015-10-07 |
| CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S363) | ABBOTT MEDICAL | 2015-10-07 |
| ON-X PROSTHETIC HEART VALVE (P000037/S043) | On-X Life Technologies, Inc. | 2015-10-05 |
| DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, ORIGEN EL ICD, ORIGEN MINI ICD (P960040/S354) | Boston Scientific | 2015-10-02 |
| ADHESIVE (P830061/S122) | Medtronic Cardiac Rhythm Disease Management | 2015-10-02 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S066) | Zoll Manufacturing Corporation | 2015-10-02 |
| END CAP,UPSIZING SLEEVE (P900061/S137) | Medtronic Cardiac Rhythm Disease Management | 2015-10-02 |
| NIRXCELL COCR CORONARY STENT ON RX SYSTEM (P110004/S013) | Medinol, Ltd. | 2015-10-02 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S065) | Medtronic, Inc. | 2015-10-02 |
| DF-1 CONNECTOR PORT PIN PLUG,IS-1 CONNECTOR PORT PIN PLUG KIT,SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE CS/SVC LEA (P920015/S162) | Medtronic, Inc. | 2015-10-02 |
| CAPSUREFIX MRI LEAD (P090013/S199) | Medtronic, Inc. | 2015-10-02 |
| SUREFIX LEAD (P930039/S137) | Medtronic, Inc. | 2015-10-02 |
| INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S002) | Boston Scientific Corporation | 2015-10-02 |
| MYOCARDIAL PACING LEAD (P120017/S001) | Medtronic, Inc. | 2015-10-02 |
| ATTAIN ABILITY LEAD (P080006/S084) | Medtronic, Inc. | 2015-10-02 |
| SERVICE KIT-PACEMAKER REPAIR KIT,VITATRON BRILLIANT S+ VDD LEAD (P890003/S337) | Medtronic, Inc. | 2015-10-02 |
| DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D (P010012/S399) | Boston Scientific Corp | 2015-10-02 |
| QUARTET FAMILY OF CRT LEADS (P030054/S290) | ABBOTT MEDICAL | 2015-10-02 |
| ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD (P010015/S280) | Medtronic, Inc. | 2015-10-02 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003) | Boston Scientific Corporation | 2015-10-02 |
| NIRXCELL COCR CORONARY STENT ON RX SYSTEM (P110004/S014) | Medinol, Ltd. | 2015-10-01 |
| BLAZER II XP, BLAZER PRIME XP, INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS (P020025/S079) | Boston Scientific | 2015-10-01 |
| BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS (P920047/S085) | Boston Scientific Corp | 2015-10-01 |
| ANGIO-SEAL (P930038/S078) | Terumo Medical Corporation | 2015-09-30 |
| ELCA CORONARY LASER ATHERECTOMY CATHETERS (P910001/S080) | Spectranetics Corp. | 2015-09-30 |
| MYCARELINK MONITOR 24950 (P890003/S334) | Medtronic, Inc. | 2015-09-30 |
| VASCADE VASCULAR CLOSURE SYSTEM (VCS) (P120016/S014) | Cardiva Medical, Inc. | 2015-09-30 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (OTW AND MR) (P100023/S122) | Boston Scientific Corp | 2015-09-29 |
| ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG (P980035/S438) | Medtronic, Inc. | 2015-09-29 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS (P110013/S057) | Medtronic Vascular | 2015-09-29 |
| CRYOABLATION SYSTEM (P020045/S067) | Medtronic Cryocath, LP | 2015-09-28 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S033) | Boston Scientific Corp | 2015-09-25 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S046) | Medtronic | 2015-09-25 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S019) | Cryolife, Inc. | 2015-09-24 |
| XIENCE V AND NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S128) | Abbott Vascular, Inc. | 2015-09-23 |
| FINELINE II STEROX ENDOCARDIAL PACING LOEADS & FINELINE II STEROX EZ ENDOCARDIAL PACING LEADS (P960004/S073) | Boston Scientific | 2015-09-23 |
| XIENCE PRIME/LL, XPEDITION, XPEDITION SV,LL, AND ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S075) | Abbott Vascular | 2015-09-23 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S122) | W. L. Gore & Associates, Inc. | 2015-09-23 |
| TRIFECTA VALVE (P100029/S020) | ABBOTT MEDICAL | 2015-09-22 |