| VITA ENHANCR II (P990001/S116) | Medtronic, Inc. | 2014-01-16 |
| CAPSURE FIX LEAD, CAPSUREFIX NOVUS, SUREFIX, & VITATRON CRYSTALLINE LEADS (P930039/S101) | Medtronic, Inc. | 2014-01-16 |
| SPRINT QUATTRO & TRANSVENE CS/SVC LEADS (P920015/S127) | Medtronic, Inc. | 2014-01-16 |
| ATTAIN STARFIX LEAD MODEL 4195 (P060039/S054) | Medtronic, Inc. | 2014-01-16 |
| SELECTSECURE LEAD (P030036/S069) | Medtronic Cardiac Rhythm Disease Management | 2014-01-16 |
| ATTAIN BIPOLAR OTW LEAD,CONSULTA CRT-P,LEFT VENTRICULAR PACING LEAD,SYNCRA CRT-P (P010015/S231) | Medtronic, Inc. | 2014-01-16 |
| EVERA S DR , S VR XT DR , XT VR . MAXIMO II , PROTECTA, XT ICD, RV, SECURA, VIRTUOSO II DR/VR ICDS/ (P980016/S453) | Medtronic Cardiac Rhythm Disease Management | 2014-01-16 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S057) | Medtronic, Inc. | 2014-01-16 |
| MYCARELINK PATIENT MONITOR, MYCARELINK READER FRU (P890003/S300) | Medtronic, Inc. | 2014-01-16 |
| SELECT SECURE LEAD (P030036/S068) | Medtronic Cardiac Rhythm Disease Management | 2014-01-16 |
| SPRINT QUATTRO LEAD & HV SPLITTER/ADAPTOR KIT (P920015/S128) | Medtronic, Inc. | 2014-01-16 |
| ATTAIN ABILITY LEAD (P080006/S065) | Medtronic, Inc. | 2014-01-16 |
| ACE HEADER, APPLICATION SOFTWARE, DEFRILLATION SUPPORT DEVICE (DISD) END CAP, EPICCARDIAL PATCH LEAD SIZILING SLEEVE UPS (P900061/S126) | Medtronic Cardiac Rhythm Disease Management | 2014-01-16 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S011) | Abbott Vascular, Inc. | 2014-01-16 |
| CAPSURE LEAD (P890003/S301) | Medtronic, Inc. | 2014-01-16 |
| RF MARINR MC (7FR), RF MARINR 5FR, RF CONTACTR, RF CONDUCTR, RF ENHANCR II, (P930029/S040) | Medtronic, Inc. | 2014-01-16 |
| APPLICATION SOFTWARE, EVERA S DR ICD, S VR ICD, XT VR DR ICD, XT VR ICD, MAXIMO II ICD, PROTECTA ICD XT ICD, RV LEAD (P970012/S094) | Medtronic, Inc. | 2014-01-16 |
| CAPSUREFIX NOVUS LEAD,VITATRON CRYSTALLINE LEAD (P930039/S102) | Medtronic, Inc. | 2014-01-16 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S056) | Medtronic, Inc. | 2014-01-16 |
| CAPSURE LEAD, CARELINK, ENCORE AND REVEAL PROGRAMMER, MONITOR READER & SOFTWARE (P890003/S298) | Medtronic, Inc. | 2014-01-16 |
| ATTAIN STARFIX LEAD (P060039/S055) | Medtronic, Inc. | 2014-01-16 |
| STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S031) | Abbott Vascular Devices | 2014-01-16 |
| ATTAIN ABILITY LEAD MODELS 4196, 4296 ,4396 (P080006/S064) | Medtronic, Inc. | 2014-01-16 |
| CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD (P850089/S104) | Medtronic Cardiac Rhythm Disease Management | 2014-01-16 |
| INCHECK PATIENT ASSISTANCE, TRANSVENE CS/SVC LEAD (P980050/S089) | Medtronic, Inc. | 2014-01-16 |
| CVX-300 EXCIMER LASER SYSTEM (P910001/S065) | Spectranetics Corp. | 2014-01-14 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S073) | Medtronic, Ireland | 2014-01-14 |
| COMPLETE SE SFA/PPA VASCULAR STENT SYSTEM (P110040/S002) | Medtronic Vascular | 2014-01-14 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S069) | Spectranetics Corp. | 2014-01-14 |
| COMPLETE SE ILIAC VASCULAR STENT SYSTEM (P090006/S012) | Medtronic Vascular | 2014-01-14 |
| XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S055) | Abbott Vascular | 2014-01-14 |
| RESOLUTE INTEGRITY CORONARY STENT SYSTEM (P110013/S032) | Medtronic Vascular | 2014-01-14 |
| SPECTRANETICS LASER SHEATHS SLS (P960042/S047) | Spectranetics (Philips) | 2014-01-14 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S031) | Medtronic Vascular | 2014-01-14 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S085) | Medtronic, Inc. | 2014-01-14 |
| TALENT AAA STENT GRAFT WITH XCELERANT HYRO DELIVERY SYSTEM (P070027/S037) | Medtronic Vascular | 2014-01-14 |
| VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S015) | Medtronic Vascular | 2014-01-14 |
| ASSURANT COBALT ILIAC BALLON-EXPANDABLE STENT SYSTEM (P110011/S006) | Medtronic, Ireland | 2014-01-14 |
| MYCARELINK PATIENT MONITOR (P890003/S294) | Medtronic, Inc. | 2014-01-09 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S356) | Medtronic, Inc. | 2014-01-08 |
| XIENCE PRIME EVEROLIMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM; XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYS (P110019/S059) | Abbott Vascular | 2014-01-08 |
| CAPSUREFIX MRI LEAD (P090013/S121) | Medtronic, Inc. | 2014-01-08 |
| CAPSUREFIX NOVUS LEAD (P930039/S098) | Medtronic, Inc. | 2014-01-08 |
| CAPSURE LEAD (P830061/S102) | Medtronic Cardiac Rhythm Disease Management | 2014-01-08 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S118) | Abbott Vascular, Inc. | 2014-01-08 |
| XIENCE XPEDITION,XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S058) | Abbott Vascular | 2014-01-07 |
| VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM (P100040/S013) | Medtronic Vascular | 2014-01-07 |
| SELOX ST 53,SELOX ST 60,SELOX JT 45,SELOX JT 53,SETROX S 45,SETROX S53,SETROX S60,DEXTRUS 4135,DEXTRUS 4136,DETRUS 4137, (P950037/S133) | Biotronik, Inc. | 2014-01-06 |
| ATTAIN ABILITY LEAD (P080006/S052) | Medtronic, Inc. | 2013-12-24 |
| ATTAIN STARFIX LEAD (P060039/S044) | Medtronic, Inc. | 2013-12-24 |
| ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA MRI IPG,RELIA IPG (P980035/S319) | Medtronic, Inc. | 2013-12-24 |
| CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,IMPULSE II LEAD (P850089/S095) | Medtronic Cardiac Rhythm Disease Management | 2013-12-24 |
| SELECT SECURE LEAD (P030036/S056) | Medtronic Cardiac Rhythm Disease Management | 2013-12-24 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S021) | Syncardia Systems, LLC | 2013-12-24 |
| TRANSVENE LEAD (P980050/S081) | Medtronic, Inc. | 2013-12-24 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE LEAD (P930039/S085) | Medtronic, Inc. | 2013-12-24 |
| EPICARDIAL PATCH LEAD (P900061/S120) | Medtronic Cardiac Rhythm Disease Management | 2013-12-24 |
| CAPSURE LEAD (P890003/S272) | Medtronic, Inc. | 2013-12-24 |
| MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRTUOSO II DR/VR IC (P980016/S412) | Medtronic Cardiac Rhythm Disease Management | 2013-12-24 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S048) | Medtronic, Inc. | 2013-12-24 |
| CAPSURE LEAD,CAPSURE SP LEAD,VITATRON CRYSTALINE LEAD,VITATRON EXCELLENCE PS+LEAD (P830061/S089) | Medtronic Cardiac Rhythm Disease Management | 2013-12-24 |
| CAPSUREFIX MRI LEAD, REVO MRI IPG (P090013/S091) | Medtronic, Inc. | 2013-12-24 |
| ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD, SYNCRA CRT-P (P010015/S197) | Medtronic, Inc. | 2013-12-24 |
| SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE SVC LEAD (P920015/S109) | Medtronic, Inc. | 2013-12-24 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D,& XT CRT-D, BRAVA CRT-D, VIVA S CRT-D (P010031/S372) | Medtronic Cardiac Rhythm Disease Management | 2013-12-24 |
| PUNCTUA, ENERGEN, INCEPTA, AND TELIGEN ICD (P960040/S297) | Boston Scientific | 2013-12-23 |
| SPRINT QUATTRO LEAD (P920015/S126) | Medtronic, Inc. | 2013-12-23 |
| VITATRON CRYSTALLINE LEAD (P930039/S100) | Medtronic, Inc. | 2013-12-23 |
| CAPSURE LEAD (P890003/S296) | Medtronic, Inc. | 2013-12-23 |
| ARTEGRAFT BOVINE HETEROGRAFT (N16837/S011) | LeMaitre Vascular, Inc. | 2013-12-23 |
| EPICARDIAL PATCH LEAD (P900061/S125) | Medtronic Cardiac Rhythm Disease Management | 2013-12-23 |
| PUNCTUA, ENERGEN INCEPTA COGNIS (P010012/S332) | Boston Scientific Corp | 2013-12-23 |
| PROMUS ELEMENT PLUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S063) | Boston Scientific Corp | 2013-12-20 |
| OMNILINK ELITE VASCULAR BALLON-EXPANDABEL STENT SYSTEM (P110043/S004) | Abbott Vascular-Cardiac Therapies | 2013-12-20 |
| WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S050) | Boston Scientific Corp | 2013-12-20 |
| WALLSTENT (VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S039) | Boston Scientific Corporation | 2013-12-20 |
| LIFEVEST DEVICE (P010030/S045) | Zoll Manufacturing Corporation | 2013-12-20 |
| EXPRESS2 CORONARY STENT SYSTEM (P020009/S112) | Boston Scientific Scimed, Inc. | 2013-12-20 |
| LIFEVEST® WEARABLE DEFIBRILLATOR (P010030/S046) | Zoll Manufacturing Corporation | 2013-12-20 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S020) | Medtronic | 2013-12-20 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S051) | Boston Scientific Corp | 2013-12-20 |
| WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S042) | Boston Scientific Scimed, Inc. | 2013-12-20 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S118) | Boston Scientific Scimed, Inc. | 2013-12-20 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYTEM (P100023/S081) | Boston Scientific Corp | 2013-12-20 |
| XIENCE PRIME EVERLIMUS CORONARY STENT SYSTEM (P110019/S050) | Abbott Vascular | 2013-12-19 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROTHESIS (P000007/S044) | Edwards Lifesciences, LLC | 2013-12-19 |
| NIRXCELL COCR CORONARY STENT ON RX SYSTEM (P110004/S001) | Medinol, Ltd. | 2013-12-19 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESES DEVICE FAMILIES (P860057/S115) | Edwards Lifesciences, LLC | 2013-12-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S033) | Edwards Lifesciences, LLC | 2013-12-19 |
| RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORNARY STENT SYSTEM; RESOLUTE INTEGRITY OTW ZOTAROLINUS ELUTING STENT SYSTEM (P110013/S031) | Medtronic Vascular | 2013-12-19 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING,CARPENTIER-EDWARDS DURAFLEX LOW (P870077/S057) | Edwards Lifesciences, LLC | 2013-12-19 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROTHESIS (P010041/S046) | Edwards Lifesciences, LLC | 2013-12-19 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S058) | Thoratec Laboratories Corp. | 2013-12-19 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S046) | Edwards Lifesciences, LLC | 2013-12-19 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS,PORCINE VALVED CONDUIT (P870056/S063) | Edwards Lifesciences, LLC | 2013-12-19 |
| REGENT, STANDARD AND MASTERS MECHANICAL HEART VALVE (P810002/S088) | ABBOTT MEDICAL | 2013-12-19 |
| INTEGRITY RX CORONARY STENT SYSTEM; INTEGRITY OTW CORONARY STENT SYSTEM (P030009/S072) | Medtronic, Ireland | 2013-12-19 |
| WALLSTENT SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND UNISTEP PLUS DELIVERY SYSTEM (12 MM VENOUS ENDOPROSTHESIS) (P980033/S040) | Boston Scientific Corporation | 2013-12-18 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE SYSTEMS) (P100023/S082) | Boston Scientific Corp | 2013-12-18 |
| CORONARY FLEXTOME CUTTING BALLOON (P950020/S066) | Boston Scientific Corp | 2013-12-18 |