| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S347) | Medtronic Cardiac Rhythm Disease Management | 2013-02-25 |
| CURRENT+,EPIC II/EPIC II+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICD DEVICES (P910023/S313) | ABBOTT MEDICAL | 2013-02-25 |
| PROMOTE+, UNIFY, UNIFY QUADRA, QUADRA ASSURA FAMILY OF CRT-D DEVICES (P030054/S243) | ABBOTT MEDICAL | 2013-02-25 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S346) | Medtronic Cardiac Rhythm Disease Management | 2013-02-25 |
| ARTEGRAFT COLLEGEN VASCULAR GRAFT (N16837/S010) | LeMaitre Vascular, Inc. | 2013-02-25 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S005) | Medtronic Vascular | 2013-02-22 |
| EPT-1000 XP RF ABLATION SYSTEM (P020025/S038) | Boston Scientific | 2013-02-22 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S055) | Boston Scientific Corp | 2013-02-22 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S004) | Boston Scientific Corporation | 2013-02-21 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S003) | Boston Scientific Corporation | 2013-02-21 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S046) | Boston Scientific Corp | 2013-02-21 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S047) | Boston Scientific Corp | 2013-02-21 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (RX & OTW), XIENCE NANO EECSS (RX) (P070015/S106) | Abbott Vascular, Inc. | 2013-02-20 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S041) | Boston Scientific Corp | 2013-02-20 |
| IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) (P960040/S286) | Boston Scientific | 2013-02-20 |
| CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS (CRT-D) (P010012/S321) | Boston Scientific Corp | 2013-02-20 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S007) | Boston Scientific Corp | 2013-02-20 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S108) | Boston Scientific Scimed, Inc. | 2013-02-20 |
| XIENCE PRIME/ XIENCE PRIME LL / XIENCE EXPEDITION/ XIENCE EXPEDITION SV AND LL EVEROLIMUS ELUTING CORONARY STENT SYTEM (P110019/S040) | Abbott Vascular | 2013-02-20 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S006) | Boston Scientific Corp | 2013-02-20 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S162) | Medtronic, Inc. | 2013-02-19 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S015) | Medtronic | 2013-02-19 |
| COROX OTW 85 UP STEROID, LUMAX 300 DR-T, LUMAX 340 DR-T,LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T,LUMAX 540 DR-T, L (P050023/S060) | Biotronik, Inc. | 2013-02-19 |
| ENRHYTHM IPG (P980035/S270) | Medtronic, Inc. | 2013-02-19 |
| REVO MRI IPG, ENRHYTHM MRI IPG (P090013/S063) | Medtronic, Inc. | 2013-02-19 |
| LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER (EPTC) EXT CBL, SAFIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, EXT CBL, S (P960016/S040) | St Jude Medical | 2013-02-19 |
| SJM MASTERS HP VALVED GRAFT (P810002/S080) | ABBOTT MEDICAL | 2013-02-19 |
| KAINOX VCS,SLX 58/11-BP,SLX 58/13-BP,SLX 58/14-BP,SLX 58/15-BP,SLX 58/17-BP,LINOX S 65,LINOX S 75, LINOX T 65,LINOX T75, (P980023/S051) | Biotronik, Inc. | 2013-02-19 |
| STRATOS LV,EVIA HF,EVIA HF-T,ENTOVIS HF,ENTOVIS HF-T,COROX OTW 85 UP STEROID,COROX OTW 75-BP,COROX OTW 85-BP,COROX OTW-S (P070008/S038) | Biotronik, Inc. | 2013-02-19 |
| EVIA DR, EVIA DR-T,EVIA SR, EVIA SR-T,ENTOVIS DR, ENTOVIS DR-T,ENTOVIS SR,ENTOVIS SR-T,ESTELLA SR,ESTELLA SR-T,ECURO DR, (P950037/S118) | Biotronik, Inc. | 2013-02-19 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S003) | Cook Ireland, Ltd. | 2013-02-15 |
| QUADRIPOLAR PACING PAS (QUAD PAS) (P030054/S236) | ABBOTT MEDICAL | 2013-02-15 |
| AORFIX FLEXIBLE STENT GRAFT SYSTEM (P110032) | Lombard Medical Limited | 2013-02-14 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P110010/S045) | Boston Scientific Corp | 2013-02-14 |
| WALLSTENT (VENOUS) ENDOPROSTHESIS (P980033/S030) | Boston Scientific Corporation | 2013-02-14 |
| EXPRESS CORONARY STENT SYSTEM (P020009/S102) | Boston Scientific Scimed, Inc. | 2013-02-14 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S068) | Boston Scientific Corp | 2013-02-14 |
| WALLSTENT (TIPS) ENDOPROSTHESIS (P930031/S041) | Boston Scientific Corp | 2013-02-14 |
| ENDOTAK RELIANCE, ENDOTAK RELIANCE 4-SITE (P910073/S115) | Boston Scientific | 2013-02-14 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S120) | Boston Scientific Corp | 2013-02-14 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S107) | Boston Scientific Scimed, Inc. | 2013-02-14 |
| PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESIS (P860057/S103) | Edwards Lifesciences, LLC | 2013-02-14 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S040) | Boston Scientific Corp | 2013-02-14 |
| LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS (P980023/S049) | Biotronik, Inc. | 2013-02-13 |
| ON-X PROSTHETIC HEART VALVE (P000037/S028) | On-X Life Technologies, Inc. | 2013-02-13 |
| MODEL 5019 HIGH VOLTAGE (HV) SPLITTER/ADAPTOR KIT (P920015/S093) | Medtronic, Inc. | 2013-02-13 |
| EVIA HF,EVIA HF-T, ENTOVIS HF, ENTOVIS HF-T (P070008/S035) | Biotronik, Inc. | 2013-02-12 |
| LUMAX FAMILY OF ICD AND CRT-D (P050023/S057) | Biotronik, Inc. | 2013-02-12 |
| CORONARY FLEXTONE CUTTING BALLOON (P950020/S060) | Boston Scientific Corp | 2013-02-12 |
| PROTEGE RX CAROTID STENT SYSTEM (P060001/S017) | Medtronic Vascular, Inc. | 2013-02-12 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S007) | Abbott Vascular, Inc. | 2013-02-12 |
| EVIA/ENTOVIS/ECURO/EFFECTA/ESTELLA PULSE GENERATORS (P950037/S113) | Biotronik, Inc. | 2013-02-12 |
| MULTIPLE APPLICATION UTILITY (MAU) USED WITH ZOOM LATITIDE PROGRAMMING SYSTEM (P910077/S130) | Boston Scientific | 2013-02-12 |
| ICD PUNCTUA VR IS4 (P960040/S285) | Boston Scientific | 2013-02-08 |
| CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL 2020A, AND MODEL 2491 DDMA (P890003/S262) | Medtronic, Inc. | 2013-02-08 |
| ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR SOFTWARE MODEL 9995 (P980035/S294) | Medtronic, Inc. | 2013-02-08 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S007) | Edwards Lifesciences, LLC | 2013-02-08 |
| ENERGEN CRT-D IS4 (P010012/S320) | Boston Scientific Corp | 2013-02-08 |
| SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S021) | Edwards Lifesciences, LLC | 2013-02-08 |
| REVO MRI IPG (P090013/S083) | Medtronic, Inc. | 2013-02-07 |
| ADAPTA/VERSA/SENSIA IPG (P980035/S303) | Medtronic, Inc. | 2013-02-07 |
| CAPSURE SENSE BIPOLAR LEAD (P830061/S085) | Medtronic Cardiac Rhythm Disease Management | 2013-02-07 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S187) | Medtronic, Inc. | 2013-02-07 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, RELIA IPG (P980035/S304) | Medtronic, Inc. | 2013-02-07 |
| CAPSUREFIX MRI SURESCAN LEAD (P090013/S082) | Medtronic, Inc. | 2013-02-07 |
| CAPSUREFIX NOVUS LEAD (P930039/S082) | Medtronic, Inc. | 2013-02-07 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S395) | Medtronic Cardiac Rhythm Disease Management | 2013-02-07 |
| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S345) | Medtronic Cardiac Rhythm Disease Management | 2013-02-07 |
| VITUOSO DR, VIRTUOSO VR, VIRTUOSO II DR, VIRTUOSO II VR, SECURA DR, SECURA VR, PROTECTA XT DR, PROTECTA XT VR (P980016/S389) | Medtronic Cardiac Rhythm Disease Management | 2013-02-05 |
| XIENCE AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S093) | Abbott Vascular, Inc. | 2013-02-01 |
| PHILOS DR-T,PHILOS II DR-T, CYLOS DR-T, EVIA DR-T,EVIA SR-T, ENTOVIS DR-T,ENTOVIS SR-T (P950037/S117) | Biotronik, Inc. | 2013-01-31 |
| BELOS VR-T (P980023/S050) | Biotronik, Inc. | 2013-01-31 |
| BELOS VR-T, BELOS DR-T, BELOS A +-T, LEXOS DR-T,LEXOS VR-T,XELOS DR-T, LUMOS DR-T,LUMOS VR-T (P000009/S052) | Biotronik, Inc. | 2013-01-31 |
| STRATOS LV-T (P070008/S037) | Biotronik, Inc. | 2013-01-31 |
| LUMAX 300 DR-T,LUMAX 340 DR-T, LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T, LUMAX 540 DR-T, LUMAX 500 VR-T, LUMAX 540 (P050023/S059) | Biotronik, Inc. | 2013-01-31 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016) | Cardiva Medical, Inc. | 2013-01-31 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S006) | Edwards Lifesciences, LLC | 2013-01-30 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S044) | Boston Scientific Corp | 2013-01-30 |
| CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESES WITH THERMAFIX TISSUE PROCESS (P860057/S102) | Edwards Lifesciences, LLC | 2013-01-30 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S020) | Edwards Lifesciences, LLC | 2013-01-30 |
| VIVA XT CRT-D, VIVA S CRT-D, BRAVA CRT-D, VIVA/BRAVA/EVERA SOFTWARE APPLICATION (P010031/S318) | Medtronic Cardiac Rhythm Disease Management | 2013-01-29 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S018) | Boston Scientific Corp | 2013-01-29 |
| ION PACLITAXEL-ELUTING CHROMIUM CORONARY STENT SYSTEM (P100023/S047) | Boston Scientific Corp | 2013-01-29 |
| MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS (P890003/S253) | Medtronic, Inc. | 2013-01-29 |
| LATITUDE WAVE COMMUNICATOR (MODEL 6498) (P910077/S119) | Boston Scientific | 2013-01-28 |
| ACCULINK CAROTID STENT SYSTEM (P040012/S051) | Abbott Vascular | 2013-01-24 |
| XACT CAROTID STENT SYSTEM (P040038/S028) | Abbott Vascular, Inc. | 2013-01-24 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S046) | Cordis US Corporation | 2013-01-24 |
| ROTABLATOR ROTATIONAL ARTHERECTOMY SYSTEM (P900056/S119) | Boston Scientific Corp | 2013-01-24 |
| RX HERCULINK ELITE RENAL STENT SYSTEM (P110001/S010) | Abbott Vascular | 2013-01-24 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S006) | Abbott Vascular, Inc. | 2013-01-24 |
| BLAZER PRIME XP AND BLAZER II XP CARDIAC ABLATION CATHETERS (P020025/S037) | Boston Scientific | 2013-01-22 |
| COGNIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, INCEPTA CARDIAC RESYNCHRONICATION THERAPY-DEBIBRILLATOR,ENERGEN (P010012/S318) | Boston Scientific Corp | 2013-01-22 |
| TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARD (P960040/S284) | Boston Scientific | 2013-01-22 |
| BLAZER II AND BLAZER PRIME HTD CARDIAC ABLATION CATHETERS (P920047/S054) | Boston Scientific Corp | 2013-01-22 |
| COGNIS CRT-D, LIVIAN CRT-D, CONTAK RENEWAL 3 RF HE CRT-D (P010012/S301) | Boston Scientific Corp | 2013-01-18 |
| SPRINT QUATTRO SECURE LEAD (P920015/S104) | Medtronic, Inc. | 2013-01-17 |
| PARADYM CRT-D, PARADYM RF CRT-D (P060027/S046) | MicroPort CRM USA, Inc. | 2013-01-16 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S027) | Bard Peripheral Vascular | 2013-01-16 |
| PARADYM VR AND DR, PARADYM RF VR AND DR (P980049/S078) | MicroPort CRM USA, Inc. | 2013-01-16 |