| RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMS (P110013/S027) | Medtronic Vascular | 2013-10-23 |
| BRAVA CRT-D,CONCERTO II CRT-D, CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S403) | Medtronic Cardiac Rhythm Disease Management | 2013-10-23 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S019) | Boston Scientific Corp | 2013-10-23 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECT XT ICD,SECURA ICD (P980016/S442) | Medtronic Cardiac Rhythm Disease Management | 2013-10-23 |
| CHILLI II COOLED ABLATION CATHETER (P980003/S043) | Boston Scientific Corp | 2013-10-23 |
| BLAZER IIXP/BLAZER PRIME XP ABLATION CATHETERS AND EPT-1000 XP CARDIAC ABLATION CONTROLLER (P020025/S048) | Boston Scientific | 2013-10-23 |
| REVO MRI IPG (P090013/S115) | Medtronic, Inc. | 2013-10-23 |
| BLAZER II/ BLAZER PRIME HTD ABLATION CATHETERS (P920047/S062) | Boston Scientific Corp | 2013-10-23 |
| ZILVER PTX DRUG ELUTING PERIPHERAL STENT (P100022/S008) | Cook Ireland, Ltd. | 2013-10-22 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005) | Cardiovascular Systems, Inc. | 2013-10-21 |
| GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE (P040037/S050) | W. L. Gore & Associates, Inc. | 2013-10-18 |
| CORONARY FLEXTOME CUTTING BALLON (P950020/S065) | Boston Scientific Corp | 2013-10-18 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S128) | Boston Scientific Corp | 2013-10-18 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S127) | Boston Scientific Corp | 2013-10-18 |
| ION CORONARY STENT SYSTEM (P100023/S079) | Boston Scientific Corp | 2013-10-18 |
| WALLSTENT (TIPS) ENDOPROSTHESIS (P930031/S048) | Boston Scientific Corp | 2013-10-18 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S061) | Boston Scientific Corp | 2013-10-18 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S028) | Boston Scientific Corporation | 2013-10-18 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S078) | Boston Scientific Corp | 2013-10-18 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S111) | Boston Scientific Scimed, Inc. | 2013-10-18 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S047) | Boston Scientific | 2013-10-18 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S042) | Boston Scientific Corp | 2013-10-18 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S062) | Boston Scientific Corp | 2013-10-18 |
| WALLSTENT (VENOUS) ENDOPROSTHESIS (P980033/S037) | Boston Scientific Corporation | 2013-10-18 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S110) | Boston Scientific Scimed, Inc. | 2013-10-18 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S061) | Boston Scientific Corp | 2013-10-18 |
| EXPRESS SD RENAL MONRAIL PREMOUNTED STENT SYSTEM (P060006/S050) | Boston Scientific Corp | 2013-10-18 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S018) | Boston Scientific Corp | 2013-10-18 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S049) | Boston Scientific Corp | 2013-10-18 |
| WALLSTENT (LLIAC) ENDOPROSTHESIS (P940019/S041) | Boston Scientific Scimed, Inc. | 2013-10-18 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S021) | Boston Scientific Corp | 2013-10-18 |
| VERIFLEX CORONARY STENT SYSTEM (P040016/S117) | Boston Scientific Scimed, Inc. | 2013-10-18 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S116) | Boston Scientific Scimed, Inc. | 2013-10-18 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S020) | Boston Scientific Corp | 2013-10-18 |
| CAPSURE LEAD (P890003/S288) | Medtronic, Inc. | 2013-10-17 |
| ATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD (P010015/S222) | Medtronic, Inc. | 2013-10-17 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S052) | Medtronic, Inc. | 2013-10-17 |
| HANCOCK II BIOPROSTHETIC HEART VALVE (P980043/S044) | Medtronic, Inc. | 2013-10-17 |
| CAPSURE SP Z LEAD (P850089/S101) | Medtronic Cardiac Rhythm Disease Management | 2013-10-17 |
| CAPSURE SENSE LEAD,CAPSURE SP NOVUS LEAD,VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+ LEAD (P830061/S098) | Medtronic Cardiac Rhythm Disease Management | 2013-10-17 |
| TRANSVENE CS/SVC LEAD (P980050/S085) | Medtronic, Inc. | 2013-10-17 |
| SPRINT QUATTRO LEAD (P920015/S119) | Medtronic, Inc. | 2013-10-17 |
| SELECTSECURE LEAD (P030036/S064) | Medtronic Cardiac Rhythm Disease Management | 2013-10-17 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S052) | Medtronic, Inc. | 2013-10-17 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S030) | Medtronic | 2013-10-17 |
| CAPSUREFIX NOVUS LEAD,VITATRON CRYSTALLINE LEAD (P930039/S094) | Medtronic, Inc. | 2013-10-17 |
| ATTAIN ABILITY LEAD (P080006/S058) | Medtronic, Inc. | 2013-10-17 |
| CONSULTA CRT-P; SYNCRA CRT-P (P010015/S220) | Medtronic, Inc. | 2013-10-17 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S044) | Medtronic, Inc. | 2013-10-17 |
| GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S057) | W. L. Gore & Associates, Inc. | 2013-10-17 |
| ATTAIN STARFIX LEAD (P060039/S051) | Medtronic, Inc. | 2013-10-17 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S011) | Medtronic Vascular | 2013-10-17 |
| GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S056) | W. L. Gore & Associates, Inc. | 2013-10-16 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S009) | Cook Ireland, Ltd. | 2013-10-16 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S002) | Cook Ireland, Ltd. | 2013-10-16 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S012) | Medtronic Vascular | 2013-10-15 |
| CONSULTA CRT D, MAXIMO II CRT-D, CONCERTO II CRT -D, CONCERTO CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA XT CRT-D, V (P010031/S394) | Medtronic Cardiac Rhythm Disease Management | 2013-10-15 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S212) | Medtronic, Inc. | 2013-10-15 |
| REVO MRI (P090013/S110) | Medtronic, Inc. | 2013-10-15 |
| ADVISA, ENRHYTHM MRI (P980035/S341) | Medtronic, Inc. | 2013-10-15 |
| REVEAL DX, REVEAL XT (P890003/S284) | Medtronic, Inc. | 2013-10-15 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S075) | Medtronic, Inc. | 2013-10-15 |
| ENTRUST, VIRTUOSO, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, INSYNC MARQUIS, PROTECTA XT, DR, PROTEXTA DR, PROTEXTA XT, VR, (P980016/S433) | Medtronic Cardiac Rhythm Disease Management | 2013-10-15 |
| CARPENTIER - EDEARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S113) | Edwards Lifesciences, LLC | 2013-10-11 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S054) | Thoratec Laboratories Corp. | 2013-10-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES-RETROFLEX 3 DELIVERY SYSTEM, EDWARDS TRANSFEMORAL BALLOON CATHE (P100041/S040) | Edwards Lifesciences, LLC | 2013-10-11 |
| CARTENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING (P870077/S056) | Edwards Lifesciences, LLC | 2013-10-11 |
| CARPENTIER- EDWARDS PORCINE BIOPROSTHESIS (P870056/S062) | Edwards Lifesciences, LLC | 2013-10-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, CRIMPER ASCENDRA BALLOON CATHETER (P110021/S027) | Edwards Lifesciences, LLC | 2013-10-11 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S043) | Edwards Lifesciences, LLC | 2013-10-11 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S045) | Edwards Lifesciences, LLC | 2013-10-11 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD (P980016/S440) | Medtronic Cardiac Rhythm Disease Management | 2013-10-10 |
| CAPSUREFIX MRI LEAD (P090013/S114) | Medtronic, Inc. | 2013-10-10 |
| ADPATA, VERA SENSIA IPG, RELIA IPG (P980035/S346) | Medtronic, Inc. | 2013-10-10 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S051) | Medtronic, Inc. | 2013-10-10 |
| REVO MRI IPG (P090013/S113) | Medtronic, Inc. | 2013-10-10 |
| SELECTSECURE LEAD (P030036/S062) | Medtronic Cardiac Rhythm Disease Management | 2013-10-10 |
| PRODIGY IPG (P890003/S286) | Medtronic, Inc. | 2013-10-10 |
| INTUA (P030005/S103) | Guidant Corp. | 2013-10-10 |
| CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,VITATRON CRYSTALLINE LEAD (P930039/S093) | Medtronic, Inc. | 2013-10-10 |
| SPRINT QUATTRO LEAD (P920015/S118) | Medtronic, Inc. | 2013-10-10 |
| CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,VITATRON IMPULSE II LEAD (P850089/S100) | Medtronic Cardiac Rhythm Disease Management | 2013-10-10 |
| TRANSVENE,SQ,SPRINT AND SPRINT FIDELIS LEAD MODELS AND ACCESSORIES (P920015/S116) | Medtronic, Inc. | 2013-10-10 |
| BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S400) | Medtronic Cardiac Rhythm Disease Management | 2013-10-10 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, INVIVE (N970003/S156) | Boston Scientific Corp | 2013-10-10 |
| CAPSURE LEAD (P890003/S287) | Medtronic, Inc. | 2013-10-10 |
| EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD (P980016/S439) | Medtronic Cardiac Rhythm Disease Management | 2013-10-10 |
| ADVISA DR IPG,ADVISA DR MRI IPG (P980035/S345) | Medtronic, Inc. | 2013-10-10 |
| CAPSURE SENSE LEAD,CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+ LEAD (P830061/S097) | Medtronic Cardiac Rhythm Disease Management | 2013-10-10 |
| BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S401) | Medtronic Cardiac Rhythm Disease Management | 2013-10-10 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S218) | Medtronic, Inc. | 2013-10-10 |
| ATTAIN STARFIX LEAD (P060039/S050) | Medtronic, Inc. | 2013-10-10 |
| ATTAIN BIPOLAR OTW LEAD,LEFT VENTICULAR PACING LEAD (P010015/S219) | Medtronic, Inc. | 2013-10-10 |
| SELECTSECURE LEAD (P030036/S061) | Medtronic Cardiac Rhythm Disease Management | 2013-10-10 |
| NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, CELSIUS RMT THERMOCOOL (P950005/S046) | Biosense Webster, Inc. | 2013-10-09 |
| OPEN PIVOT HEART VALVE (P990046/S036) | Medtronic Ats Medical, Inc. | 2013-10-09 |
| THERMOCOOL SF (P040036/S040) | Biosense Webster, Inc. | 2013-10-09 |
| EZ STEER (P030031/S057) | Biosense Webster, Inc. | 2013-10-09 |
| EXCLUDER AAA ENDOPROSTHESIS SIM-PULL (P020004/S087) | W. L. Gore & Associates, Inc. | 2013-10-08 |
| EPT-1000XP CARDIAC ABLATION SYSTEM (P020025/S044) | Boston Scientific | 2013-10-07 |