| ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR (P980035/S277) | Medtronic, Inc. | 2013-01-15 |
| VITATRON CRYSTALLINE LEAD (P930039/S081) | Medtronic, Inc. | 2013-01-15 |
| INVIVE CARDIAC RESYNCHRONIZATION THERAPY - PACEMAKER (CRT-P) (P030005/S096) | Guidant Corp. | 2013-01-15 |
| INTEGRITY RX CORONARY STENT SYSTEM, INTEGRITY OTW CORONARY STENT SYSTEM (P030009/S062) | Medtronic, Ireland | 2013-01-15 |
| CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER (P890003/S252) | Medtronic, Inc. | 2013-01-15 |
| SPRINT QUATTRO LEAD (P920015/S103) | Medtronic, Inc. | 2013-01-15 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S045) | W. L. Gore & Associates, Inc. | 2013-01-15 |
| COROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEAD (P050023/S056) | Biotronik, Inc. | 2013-01-11 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S036) | Medtronic, Inc. | 2013-01-10 |
| HANCOCK LOW POROSITY CONDUIT MODEL 105 (P870078/S015) | Medtronic, Inc. | 2013-01-10 |
| INCEPTA, ENERGEN, PUNCTUA, COGNIS CRT-D'S (P010012/S317) | Boston Scientific Corp | 2013-01-10 |
| INCEPTA, ENERGEN, PUNCTUA, TELIGEN ICD'S (P960040/S283) | Boston Scientific | 2013-01-10 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S034) | Medtronic, Inc. | 2013-01-10 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S041) | Medtronic, Inc. | 2013-01-10 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S017) | Spectranetics Corp. | 2013-01-10 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT MODEL 150 (P790007/S032) | Medtronic Heart Valves | 2013-01-10 |
| INVIVE CRT-P (P030005/S094) | Guidant Corp. | 2013-01-10 |
| MYNX CADENCE AND MYNXGRIP VASCULAR CLOSURE DEVICES (P040044/S044) | Cordis US Corporation | 2013-01-09 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S039) | Boston Scientific Corp | 2013-01-09 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) (P100023/S067) | Boston Scientific Corp | 2013-01-08 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S046) | Medtronic, Inc. | 2013-01-08 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S034) | Medtronic Heart Valves | 2013-01-08 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) (P110010/S043) | Boston Scientific Corp | 2013-01-08 |
| ON-X PROSTHETIC HEART VALVE (P000037/S032) | On-X Life Technologies, Inc. | 2013-01-08 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S101) | Edwards Lifesciences, LLC | 2013-01-08 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S038) | Medtronic, Inc. | 2013-01-08 |
| CVX-300 EXCIMER LASER SYSTEM (P910001/S063) | Spectranetics Corp. | 2013-01-08 |
| HANCOCK PORCINE BIOPROSTHESIS (P870078/S018) | Medtronic, Inc. | 2013-01-08 |
| HANCOCK II BIOPROSTHETIC HEART VALVE (P980043/S038) | Medtronic, Inc. | 2013-01-08 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S008) | Medtronic | 2013-01-07 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S044) | W. L. Gore & Associates, Inc. | 2013-01-04 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S004) | Medtronic | 2013-01-04 |
| CAPSURE LEAD, CAPSURE SENSE BIPOLAR LEAD, VISTATRON CRYSTALINE LEAD, VISTRATRON EXCELLENCE PS+ LEAD (P830061/S084) | Medtronic Cardiac Rhythm Disease Management | 2013-01-03 |
| ATTAIN STARFIX LEAD (P060039/S041) | Medtronic, Inc. | 2013-01-03 |
| CONCERTO ICD, II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD,INSYNC MAXIMO ICD, II CRT-D,PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S315) | Medtronic Cardiac Rhythm Disease Management | 2013-01-03 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S011) | Medtronic | 2013-01-03 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S343) | Medtronic Cardiac Rhythm Disease Management | 2013-01-03 |
| ATTAIN BIPOLAR OTW LEAD (P010015/S186) | Medtronic, Inc. | 2013-01-03 |
| CAPSURE LEAD (P890003/S267) | Medtronic, Inc. | 2013-01-03 |
| ENTRUST ICD,INTRINSIC ICD,MARQUIS DR ICD,VR ICD,MAXIMO II ICD,VR ICD,PROTECTA ICD,XT ICD,SECURA ICD,VIRTUOSO ICD (P980016/S363) | Medtronic Cardiac Rhythm Disease Management | 2013-01-03 |
| Y ADAPTOR/EXTENDER KIT, SPRINT QUATTRO LEAD (P920015/S102) | Medtronic, Inc. | 2013-01-03 |
| CAPSURE SP NOVUS LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD (P850089/S092) | Medtronic Cardiac Rhythm Disease Management | 2013-01-03 |
| SUREFIX LEAD (P930039/S080) | Medtronic, Inc. | 2013-01-03 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S393) | Medtronic Cardiac Rhythm Disease Management | 2013-01-03 |
| ATTAIN ABILITY LEAD (P080006/S049) | Medtronic, Inc. | 2013-01-03 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S012) | Medtronic | 2013-01-02 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO (P860057/S099) | Edwards Lifesciences, LLC | 2012-12-28 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S007) | Medtronic | 2012-12-28 |
| EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S008) | Cordis US Corporation | 2012-12-28 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S037) | Medtronic, Inc. | 2012-12-28 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S117) | Boston Scientific Corp | 2012-12-28 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S040) | Endologix, LLC | 2012-12-28 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S045) | Medtronic, Inc. | 2012-12-28 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S050) | Thoratec Laboratories Corp. | 2012-12-27 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S050) | W. L. Gore & Associates, Inc. | 2012-12-27 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S079) | W. L. Gore & Associates, Inc. | 2012-12-27 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S003) | Medtronic | 2012-12-27 |
| SPRINT QUATTRO LEAD (P920015/S101) | Medtronic, Inc. | 2012-12-26 |
| ATTAIN BIPOLAR OTW LEAD (P010015/S185) | Medtronic, Inc. | 2012-12-26 |
| ATTAIN STARFIX LEAD (P060039/S040) | Medtronic, Inc. | 2012-12-26 |
| SPECTRANETICS LASER SHEATHS SLS (P960042/S045) | Spectranetics (Philips) | 2012-12-26 |
| GORE HELIX SEPTAL OCCLUDER (P050006/S033) | W. L. Gore & Associates, Inc. | 2012-12-26 |
| CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS + LEAD (P830061/S083) | Medtronic Cardiac Rhythm Disease Management | 2012-12-26 |
| CASUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEAD (P930039/S079) | Medtronic, Inc. | 2012-12-26 |
| ENDURANT STENT GRAFT SYSTEM (P100021/S018) | Medtronic Vascular | 2012-12-26 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S002) | Medtronic | 2012-12-26 |
| ATTAIN ABILITY LEAD (P080006/S048) | Medtronic, Inc. | 2012-12-26 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S062) | Spectranetics Corp. | 2012-12-26 |
| TELIGEN 4-SITE HEADER ICD MODELS (P960040/S262) | Boston Scientific | 2012-12-21 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S101) | Boston Scientific Scimed, Inc. | 2012-12-21 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S039) | Boston Scientific Corp | 2012-12-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S080) | W. L. Gore & Associates, Inc. | 2012-12-21 |
| ENDOTAK RELIANCE 4-SITE LEAD AND ACCESSORY MODELS (P910073/S102) | Boston Scientific | 2012-12-21 |
| ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S066) | Boston Scientific Corp | 2012-12-21 |
| OVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980049/S061) | MicroPort CRM USA, Inc. | 2012-12-21 |
| XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S025) | Abbott Vascular | 2012-12-21 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S001) | Medtronic | 2012-12-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS WITH C3 DELIVERY SYSTEM (P020004/S078) | W. L. Gore & Associates, Inc. | 2012-12-21 |
| TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S102) | Boston Scientific Corp | 2012-12-21 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S042) | Boston Scientific Corp | 2012-12-21 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S020) | Boston Scientific Corporation | 2012-12-21 |
| COGNIS 4-SITE HEADER CRT-D MODELS (P010012/S292) | Boston Scientific Corp | 2012-12-21 |
| RF ENCHANCER II ABLATION CATHETER (P930029/S038) | Medtronic, Inc. | 2012-12-21 |
| TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S100) | Boston Scientific Corp | 2012-12-21 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S026) | Boston Scientific Corp | 2012-12-21 |
| VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S106) | Boston Scientific Scimed, Inc. | 2012-12-21 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S002) | Medtronic Vascular | 2012-12-21 |
| RELIANCE 4-SITE DEFIBRILLATOR LEAD (P910073/S107) | Boston Scientific | 2012-12-20 |
| CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS + LEAD (P830061/S082) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |
| ADAPTOR (P820003/S119) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |
| VITATRON C20 SR IPG, VITATRON C60 DR IPG, VITATRON T20 SR IPG, VITATRON T60 DR IPG (P990001/S109) | Medtronic, Inc. | 2012-12-20 |
| RF CONDUCTR, RF CONTACTR, RF ENHANCER II, RF MARINR, RF MARINR UNIPOLAR (P930029/S037) | Medtronic, Inc. | 2012-12-20 |
| ACE HEADER, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE (P900061/S118) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |
| ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD, SYNCRA CRT-P (P010015/S184) | Medtronic, Inc. | 2012-12-20 |
| CAPSURE LEAD, PRODIGY IPG, SERVICE KIT-PACEMAKER REPAIR KIT (P890003/S266) | Medtronic, Inc. | 2012-12-20 |
| CONCERTO ICD, CONCERTO II CRT-D & DF4 ICD, CONSULTA ICD, INSYNC II MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D (P010031/S342) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |
| ATTAIN ABILITY LEAD (P080006/S047) | Medtronic, Inc. | 2012-12-20 |
| LIFEVEST WEARABLE DEBRILLATOR (P010030/S039) | Zoll Manufacturing Corporation | 2012-12-20 |
| REVO MRI IPG (P090013/S081) | Medtronic, Inc. | 2012-12-20 |
| INTRINSIC ICD, MARQUIS DR ICD, & VR ICD, MAXIMO DR ICD, MAXIMO II ICD & VR ICD, PROTECTA ICD & XT ICD, SECURA ICD (P980016/S392) | Medtronic Cardiac Rhythm Disease Management | 2012-12-20 |