| LEGOO (P110003/S004) | Genzyme Corp. | 2014-03-26 |
| ION PACLITAXEL -ELUTING CORONARY STENT SYSTEM (P100023/S089) | Boston Scientific Corp | 2014-03-26 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S066) | Boston Scientific Corp | 2014-03-26 |
| XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, OTW PLATFORM (P110019/S061) | Abbott Vascular | 2014-03-26 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE (P900056/S133) | Boston Scientific Corp | 2014-03-26 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S056) | Boston Scientific Corp | 2014-03-26 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S077) | Boston Scientific Corp | 2014-03-26 |
| PROXIMAL (D01) CONNECTOR (P820003/S127) | Medtronic Cardiac Rhythm Disease Management | 2014-03-26 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S057) | Boston Scientific Corp | 2014-03-25 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S125) | Boston Scientific Scimed, Inc. | 2014-03-25 |
| EXPRESS MONORAIL AND OTW CORONARY STENT SYSTEM (P020009/S119) | Boston Scientific Scimed, Inc. | 2014-03-25 |
| ION (TAXUS ELEMENT) CORONARY STENT SYSTEM (P100023/S090) | Boston Scientific Corp | 2014-03-25 |
| THERAPY COOL PATH CATHETER (6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6 HOLE IRRIGATED), SAFIRE BLU SP (P060019/S026) | Irvine Biomedical, Inc. | 2014-03-21 |
| THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHETER (NON-IRRIGATED), SAFIRE TX CATHETER (P040042/S026) | Irvine Biomedical,Inc.(Ibi) | 2014-03-21 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S072) | Terumo Medical Corporation | 2014-03-21 |
| LIVEWIRE TC ABLATION CATHETER (NON-IRRIGATED),SAFIRE ABLATION CATHETER (NON-IRRIGATED) (P960016/S044) | St Jude Medical | 2014-03-21 |
| THERAPY CATHETER (NON-IRRIGATED) (P040014/S021) | Irvine Biomedical, Inc. | 2014-03-21 |
| THERAPY COOL PATH DUO CATHETER(12 HOLE IRRIGATED),SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED),COOL PATH DUO ABLATION (P110016/S010) | ABBOTT MEDICAL | 2014-03-21 |
| CAPSUREFIX MRI LEAD (P090013/S134) | Medtronic, Inc. | 2014-03-20 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S108) | ABBOTT MEDICAL | 2014-03-20 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S230) | ABBOTT MEDICAL | 2014-03-20 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S055) | ABBOTT MEDICAL | 2014-03-20 |
| LATTITUDE CONSULT SYSTEM (P910077/S138) | Boston Scientific | 2014-03-20 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S089) | MicroPort CRM USA, Inc. | 2014-03-20 |
| PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE DEVICE, PROCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM (P960043/S087) | Abbott Vascular, Inc. | 2014-03-20 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S241) | ABBOTT MEDICAL | 2014-03-20 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV) (P060038/S019) | Corcym Canada Corp | 2014-03-20 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S311) | ABBOTT MEDICAL | 2014-03-20 |
| TRIVASCULAR,INC OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S011) | Endologix, LLC | 2014-03-20 |
| CAPSUREFIX NOVUS LEAD (P930039/S106) | Medtronic, Inc. | 2014-03-20 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S425) | Medtronic Cardiac Rhythm Disease Management | 2014-03-20 |
| SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S085) | St. Jude Medical, Inc. | 2014-03-20 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S463) | Medtronic Cardiac Rhythm Disease Management | 2014-03-20 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S055) | Boston Scientific Corp | 2014-03-19 |
| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P110013/S036) | Medtronic Vascular | 2014-03-19 |
| EXPRESS 2 MONORAIL AND OTW CORONARY STENT SYSTEM (P020009/S117) | Boston Scientific Scimed, Inc. | 2014-03-19 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S089) | Medtronic, Inc. | 2014-03-19 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S075) | Medtronic, Ireland | 2014-03-19 |
| ARCTIC FRONT AND ARCTIC FRONT ADVANCE CRYOABLATION CATHETERS (P100010/S031) | Medtronic Cryocath, LP | 2014-03-19 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S123) | Boston Scientific Scimed, Inc. | 2014-03-19 |
| PARADYM ICD (P980049/S090) | MicroPort CRM USA, Inc. | 2014-03-18 |
| THORATEC VENTRICULAR ASSIST DEVICE (P870072/S059) | Thoratec Laboratories Corp. | 2014-03-18 |
| REPLY/ESPRIT PACEMAKERS (P950029/S086) | MicroPort CRM USA, Inc. | 2014-03-18 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S023) | Syncardia Systems, LLC | 2014-03-18 |
| ON-X PROSTHETIC HEART VALVE (P000037/S035) | On-X Life Technologies, Inc. | 2014-03-18 |
| THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS) (P060040/S032) | ABBOTT MEDICAL | 2014-03-18 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S088) | Boston Scientific Corp | 2014-03-14 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S119) | Edwards Lifesciences, LLC | 2014-03-14 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S039) | Medtronic | 2014-03-14 |
| CARPENTIER-EDWARDS PORCINE AORTIC AND MITRAL BIOPROSTHESIS (P870056/S065) | Edwards Lifesciences, LLC | 2014-03-14 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S048) | Edwards Lifesciences, LLC | 2014-03-14 |
| PROMUS ELEMENT PLUS / PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S076) | Boston Scientific Corp | 2014-03-14 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S035) | Medtronic Vascular | 2014-03-14 |
| DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE (P870077/S059) | Edwards Lifesciences, LLC | 2014-03-14 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S037) | Medtronic | 2014-03-13 |
| PROMUS ELEMENT PLUS / PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S075) | Boston Scientific Corp | 2014-03-13 |
| RF CONDUCTR MC,RF CONTACTR,RF ENHANCR II,RF MARINR (P930029/S041) | Medtronic, Inc. | 2014-03-13 |
| HVAD SEWING RING-HEARTWARE VENTRICULAR ASSIST SYTEM (P100047/S038) | Medtronic | 2014-03-13 |
| Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD (P920015/S131) | Medtronic, Inc. | 2014-03-12 |
| LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S043) | St Jude Medical | 2014-03-12 |
| ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S108) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S367) | Medtronic, Inc. | 2014-03-12 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S059) | Medtronic, Inc. | 2014-03-12 |
| BATTERY CHECK MONITOR, CAPSURE LEAD, CARELINK PROGRAMMER, CARELINK PROGRAMMER RF HEAD, DESKTOP BOSS SOFTWARE, ECG CABLE (P890003/S303) | Medtronic, Inc. | 2014-03-12 |
| PUNCTUA ICD, TELIGEN, ENERGEN ICD, INCEPTA ICD (P960040/S309) | Boston Scientific | 2014-03-12 |
| EGMP5 DOWNLOAD SOFTWARE APPLICATION,EVERA S DR ICD.EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PATIENT (P980016/S469) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| ATTAIN BIPOLAR OTW LEAD,CONSULTA CRT-P,LEFT VENTRICULAR PACING LEAD,SYNCRA CRT-P (P010015/S234) | Medtronic, Inc. | 2014-03-12 |
| ANCHORING SLEEVE KIT ; SELECT SECURE LEAD (P030036/S071) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD (P850089/S107) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| VITA ENHANCR II (P990001/S117) | Medtronic, Inc. | 2014-03-12 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD (P980016/S467) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| CAPSUREFIX MRI LEAD,REVO MRI IPG (P090013/S133) | Medtronic, Inc. | 2014-03-12 |
| PUNCTUA CRT-D, COGNIS, ENERGEN CRT-D, INCEPTA CRT-D (P010012/S346) | Boston Scientific Corp | 2014-03-12 |
| DISPOSABLE EPG COVER (P820003/S128) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA S CRT-D, XTCRT-D (P010031/S430) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| ATTAIN STARFIX LEAD (P060039/S057) | Medtronic, Inc. | 2014-03-12 |
| RF CONTACTR CATHETER, RF ENHANCR II CATHETER, RF MARINR CATHETER, RF CONDUCTR CATHETER (P930029/S042) | Medtronic, Inc. | 2014-03-12 |
| S-ICD SYSTEM (P110042/S027) | Boston Scientific Corporation | 2014-03-12 |
| TRANSVENE CS/SVC LEAD (P980050/S091) | Medtronic, Inc. | 2014-03-12 |
| BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S429) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| ACE HEADER, CABLE, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, PATIENT MAGNET, UPSIZING SLEEVE (P900061/S128) | Medtronic Cardiac Rhythm Disease Management | 2014-03-12 |
| ATTAIN ABILITY LEAD (P080006/S067) | Medtronic, Inc. | 2014-03-12 |
| CAPSUREFIC LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE-ACCESSORY FODR 5076 LEAD, VITATRON CRYSTALLINE (P930039/S105) | Medtronic, Inc. | 2014-03-12 |
| LUMAX 6/7 AND ILESTO/IFORIA ICD/CRT D FAMILIES (P050023/S075) | Biotronik, Inc. | 2014-03-11 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S064) | Abbott Vascular | 2014-03-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S035) | Edwards Lifesciences, LLC | 2014-03-10 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS (P040037/S061) | W. L. Gore & Associates, Inc. | 2014-03-10 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S048) | Edwards Lifesciences, LLC | 2014-03-10 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S120) | Abbott Vascular, Inc. | 2014-03-10 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S465) | Medtronic Cardiac Rhythm Disease Management | 2014-03-07 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S427) | Medtronic Cardiac Rhythm Disease Management | 2014-03-07 |
| PARADYM RF:MODELS VR 9250, DR 9550, CRT-D 9750; PARADYM MODELS VR 8250, DR 8550, CRT-D 8750 (P060027/S053) | MicroPort CRM USA, Inc. | 2014-03-06 |
| SMARTVIEW REMOTE MONITORING SYSTEM: SMARTVIEW MONITOR PSTN MODEL, GPRS MODEL (P980049/S085) | MicroPort CRM USA, Inc. | 2014-03-06 |
| CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S332) | ABBOTT MEDICAL | 2014-03-06 |
| PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUADRA, PROMOTE+, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUANDRA FAMILIES (P030054/S263) | ABBOTT MEDICAL | 2014-03-06 |
| CRYOABLATION CONSOLE (P020045/S046) | Medtronic Cryocath, LP | 2014-03-06 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S428) | Medtronic Cardiac Rhythm Disease Management | 2014-03-05 |
| BRAVA CRT-D,VIVA S CRT-D, VIVA XT CRT-D (P010031/S417) | Medtronic Cardiac Rhythm Disease Management | 2014-03-05 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S041) | Boston Scientific Corp | 2014-03-05 |
| EVERA S DR ID, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S466) | Medtronic Cardiac Rhythm Disease Management | 2014-03-05 |