| IFORIA VR-T ICD, LLESTO VR-T ICD, LUMAX VR-T ICD,IFORIA VR-T DX ICD, LLESTO VR-T DX ICD, LUMAX VR-T DX ICD, (P050023/S068) | Biotronik, Inc. | 2013-08-14 |
| MAESTRO 3000 CARDIAC ABLATION SYSTEM (P020025/S042) | Boston Scientific | 2013-08-14 |
| ECURO, EFFECTA, ESTELLA,EVIA, ENTOVIS IMPLANTABLE PACEMAKER (P950037/S126) | Biotronik, Inc. | 2013-08-14 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S388) | Medtronic Cardiac Rhythm Disease Management | 2013-08-14 |
| ENTOVIS HF(-T) CRT-P, EVIA HF(-T) CRT-P, STRATOS CRT-P (P070008/S045) | Biotronik, Inc. | 2013-08-14 |
| PARASYM CRT-D 8750 (P060027/S051) | MicroPort CRM USA, Inc. | 2013-08-13 |
| PARADYM VR 8750, PARADYM DR8750 (P980049/S083) | MicroPort CRM USA, Inc. | 2013-08-13 |
| REPLY SR, REPLY DR, ESPIRIT SR, ESPIRIT DR (P950029/S080) | MicroPort CRM USA, Inc. | 2013-08-13 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S043) | Endologix, LLC | 2013-08-12 |
| SUBCUTANEOUS IMPLANTABLE DEFIB RILLATOR (S-ICD) SYSTEM (P110042/S011) | Boston Scientific Corporation | 2013-08-12 |
| ADAPTA, VERSA, SENSIA, ADVISA DR/DR MRI, RELIA IPG'S (P980035/S339) | Medtronic, Inc. | 2013-08-12 |
| CONSULTA ICD & BRAVA, CONCERTO II, MAXIMO II,PROTECTA/PROTECTA XT, VIVA S/XT CRT- D'S (P010031/S389) | Medtronic Cardiac Rhythm Disease Management | 2013-08-12 |
| EVERA S DR/VR & XT DR/ VR, MAXIMO II, PROTECTA/PROTECTA XT, SECURA, VIRTUOSO II DR/ VR ICD'S (P980016/S428) | Medtronic Cardiac Rhythm Disease Management | 2013-08-12 |
| CONSULTA AND SYNCRA CRT-P'S (P010015/S210) | Medtronic, Inc. | 2013-08-12 |
| REVO MRI IPG (P090013/S108) | Medtronic, Inc. | 2013-08-12 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S036) | Edwards Lifesciences, LLC | 2013-08-09 |
| MODEL 5348 SINGLE CHAMBER TEMPORARY PACEMAKER (AAI/VVI) AND MODEL 5388 DUAL CHAMBER TEMPORARY PACEMAKER (P820003/S122) | Medtronic Cardiac Rhythm Disease Management | 2013-08-09 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S022) | Edwards Lifesciences, LLC | 2013-08-09 |
| REGENT, STANDARD, AND MASTERS MECHANICAL HEART VALVE (P810002/S087) | ABBOTT MEDICAL | 2013-08-08 |
| ARCTIC MODEL FRONT CARDIAC CRYOABLATION SYSTEM (P100010/S029) | Medtronic Cryocath, LP | 2013-08-07 |
| VENTAK (P830060/S075) | Boston Scientific | 2013-08-07 |
| SWEET TIP RX/ FLEXTEND LEAD FAMILY (P960006/S039) | Boston Scientific | 2013-08-07 |
| FINLINE LEAD FAMILY (P960004/S061) | Boston Scientific | 2013-08-07 |
| OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT (P990046/S035) | Medtronic Ats Medical, Inc. | 2013-08-07 |
| INTELLATIP MIFI XP- ABLATION CATHETER AND BLAZER PRIME XP CATHETER (P020025/S036) | Boston Scientific | 2013-08-07 |
| ENDOTAK LEAD FAMILY (P910073/S117) | Boston Scientific | 2013-08-07 |
| FREEZOR CARDIAC CRYOABLATION SYSTEM (P020045/S049) | Medtronic Cryocath, LP | 2013-08-07 |
| VENTAK PRX MINI (P910077/S133) | Boston Scientific | 2013-08-07 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S029) | ABBOTT MEDICAL | 2013-08-05 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S031) | W. L. Gore & Associates, Inc. | 2013-08-05 |
| GORE VIBAHN ENDOPROSTHESIS (P040037/S054) | W. L. Gore & Associates, Inc. | 2013-08-05 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S086) | W. L. Gore & Associates, Inc. | 2013-08-05 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S056) | W. L. Gore & Associates, Inc. | 2013-08-05 |
| GORE HELEX SEPTAL OCCLUDER (P050006/S036) | W. L. Gore & Associates, Inc. | 2013-08-05 |
| EDWARDS SAPIEN TRANSCATHER HEART VALVE, MODEL 9000TFX (P110021/S021) | Edwards Lifesciences, LLC | 2013-08-02 |
| EDWARDS SAPIEN TRANSCATHETER HEART, MODEL 9000TFX (P100041/S035) | Edwards Lifesciences, LLC | 2013-08-02 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S028) | Medtronic | 2013-08-02 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S049) | Medtronic, Inc. | 2013-07-31 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S041) | Medtronic, Inc. | 2013-07-31 |
| HANCOCK II BIOPROSTHETIC HEART VALVE (P980043/S041) | Medtronic, Inc. | 2013-07-31 |
| HANCOCK PORCINE BIOPROSTHESIS (P870078/S020) | Medtronic, Inc. | 2013-07-31 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S037) | Medtronic Heart Valves | 2013-07-31 |
| INCEPTA,ENERGEN,PUNCTUA CRT-DS (P010012/S337) | Boston Scientific Corp | 2013-07-30 |
| OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT (P990046/S034) | Medtronic Ats Medical, Inc. | 2013-07-30 |
| LINOX S DX (P980023/S056) | Biotronik, Inc. | 2013-07-30 |
| INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S300) | Boston Scientific | 2013-07-30 |
| HANCOCK II BIOPROSTHETIC HEART VALVE (P980043/S043) | Medtronic, Inc. | 2013-07-30 |
| ECURO, EFFECTA, ESTELLA, EVIA ENTOVIS (P950037/S125) | Biotronik, Inc. | 2013-07-30 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER (P110016/S003) | ABBOTT MEDICAL | 2013-07-30 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S039) | Medtronic Heart Valves | 2013-07-30 |
| ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S337) | Medtronic, Inc. | 2013-07-30 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S078) | Medtronic, Inc. | 2013-07-30 |
| INCEPTA,ENERGEN,PUNCTUA CRTS (P010012/S335) | Boston Scientific Corp | 2013-07-30 |
| MOSAIC PORCINE BIOPROSTHESIS (P990064/S051) | Medtronic, Inc. | 2013-07-30 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S018) | Medtronic Vascular | 2013-07-30 |
| INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S302) | Boston Scientific | 2013-07-30 |
| HANCOCK PORCINE BIOPROSTHESIS (P870078/S022) | Medtronic, Inc. | 2013-07-30 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S207) | Medtronic, Inc. | 2013-07-30 |
| LLESTO, IFORIA, LUMAX, (P050023/S067) | Biotronik, Inc. | 2013-07-30 |
| REVO MRI IPG. (P090013/S106) | Medtronic, Inc. | 2013-07-30 |
| LUMAX (P050023/S066) | Biotronik, Inc. | 2013-07-30 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S043) | Medtronic, Inc. | 2013-07-30 |
| ENTOVIS HF(-T), EVIA HF (-T) (P070008/S044) | Biotronik, Inc. | 2013-07-30 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S056) | Boston Scientific Corp | 2013-07-28 |
| ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S075) | Boston Scientific Corp | 2013-07-28 |
| XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM,XIENCE XP (P110019/S045) | Abbott Vascular | 2013-07-26 |
| ARCTIC FRONT AND ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHERTERS (P100010/S030) | Medtronic Cryocath, LP | 2013-07-26 |
| INTEGRITY CORONARY STENT SYSTEMS (P030009/S065) | Medtronic, Ireland | 2013-07-26 |
| AMPLATZER DUCT OCCLUDER (P020024/S039) | ABBOTT MEDICAL | 2013-07-26 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S003) | Medtronic, Ireland | 2013-07-26 |
| EVERA S DR ICD, EVERA S VR ICD EVERA XT DR ICD, EVERA XT VR ICD (P980016/S424) | Medtronic Cardiac Rhythm Disease Management | 2013-07-26 |
| MAXIMO II ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S423) | Medtronic Cardiac Rhythm Disease Management | 2013-07-26 |
| AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER-CRIBRIFORM (P000039/S049) | ABBOTT MEDICAL | 2013-07-26 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S019) | Medtronic Vascular | 2013-07-26 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S079) | Medtronic, Inc. | 2013-07-26 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S385) | Medtronic Cardiac Rhythm Disease Management | 2013-07-26 |
| MEDTRONIC OPEN PIVOT HEART VALVE (P990046/S033) | Medtronic Ats Medical, Inc. | 2013-07-26 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S023) | ABBOTT MEDICAL | 2013-07-26 |
| CONCERTO II CRT-D, CONSULTA ICD, MAXIMO CRT-D (P010031/S384) | Medtronic Cardiac Rhythm Disease Management | 2013-07-26 |
| CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S052) | Corcym S.r.l. | 2013-07-25 |
| ADVANTIO, INGENIO, VITALIO, AND FORMIO (N970003/S152) | Boston Scientific Corp | 2013-07-25 |
| INVIVE,INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-P) (P030005/S099) | Guidant Corp. | 2013-07-25 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S027) | Medtronic | 2013-07-25 |
| EPIC VASCULAR STENT SYSTEM (P110035/S017) | Boston Scientific Corp | 2013-07-24 |
| COGNIS, INCEPTA CRT-D , ENERGEN CRT-D PUNCTUA CRT-D (P010012/S334) | Boston Scientific Corp | 2013-07-24 |
| TELIGEN,INCEPTA,ENERGEN,PUNCTUA ICDS (P960040/S298) | Boston Scientific | 2013-07-24 |
| COGNIS,INCEPTA,ENERGEN,PUNCTUA CRT-DS (P010012/S333) | Boston Scientific Corp | 2013-07-24 |
| TELIGEN, INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD (P960040/S299) | Boston Scientific | 2013-07-24 |
| CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE-ACCESSORY FOR 5076 LEAD (P930039/S089) | Medtronic, Inc. | 2013-07-23 |
| SELECTSECURE LEAD (P030036/S058) | Medtronic Cardiac Rhythm Disease Management | 2013-07-23 |
| BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICDM INSYNC III MARQUIS (P010031/S377) | Medtronic Cardiac Rhythm Disease Management | 2013-07-23 |
| ZILVER PTX DRUG ELUTING PERIPHERAL STENT (P100022/S007) | Cook Ireland, Ltd. | 2013-07-23 |
| ATTAIN STARFIX LEAD (P060039/S047) | Medtronic, Inc. | 2013-07-23 |
| ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD (P010015/S202) | Medtronic, Inc. | 2013-07-23 |
| CAPSUREFIX MRI LEAD, REVO MRI IPG (P090013/S099) | Medtronic, Inc. | 2013-07-23 |
| TRANSVENE LEAD (P980050/S084) | Medtronic, Inc. | 2013-07-23 |
| ACE HEADER, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE (P900061/S122) | Medtronic Cardiac Rhythm Disease Management | 2013-07-23 |
| EVERA S DR ICD, S VR ICD,XT DR ICD, XT VR ICD, INTRINISIC ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, MAXIMO II ICD; VR (P980016/S417) | Medtronic Cardiac Rhythm Disease Management | 2013-07-23 |
| CAPSURE LEAD, PRODIGY IPG, SERVICE KIT-PACEMAKER REPAIR KIT (P890003/S278) | Medtronic, Inc. | 2013-07-23 |
| VITATRON C20 SR IPG , C60 DR IPG, T20 SR IPG, VITATRON T60 DR IPG (P990001/S112) | Medtronic, Inc. | 2013-07-23 |