| CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S360) | Medtronic Cardiac Rhythm Disease Management | 2013-03-20 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S189) | Medtronic, Inc. | 2013-03-20 |
| VARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC. (P950037/S116) | Biotronik, Inc. | 2013-03-18 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO ICD, VIRTUOSO II DR/VR ICD (P980016/S360) | Medtronic Cardiac Rhythm Disease Management | 2013-03-18 |
| CONCERTO ICD, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S313) | Medtronic Cardiac Rhythm Disease Management | 2013-03-18 |
| BELOS & LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S051) | Biotronik, Inc. | 2013-03-18 |
| STRATOS LV/LV-T, EVIA AND ENTOVIS HF/HF-T CRT-P'S (P070008/S036) | Biotronik, Inc. | 2013-03-18 |
| ILESTO 7/ 5 VR-T ICD, IFORIA 7/ 5 VR-T ICD, ILESTO 7/ 5 VR-T DX ICD, ILFORIA 7/ 5 VR-T DX ICD, ILESTO 7/ 5 DR-T ICD (P050023/S058) | Biotronik, Inc. | 2013-03-18 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S029) | Bard Peripheral Vascular | 2013-03-15 |
| REPLY/ESPRIT PACEMAKER FAMILY (P950029/S076) | MicroPort CRM USA, Inc. | 2013-03-14 |
| CONSULTA CRT-P, ADVISA (MODEL 9995 V8.0) CONSULTA CRT-D, SECURA (MODEL 9995 V8.0) INSYNC III, MAXIMO II, CONCERTO II (P010031/S319) | Medtronic Cardiac Rhythm Disease Management | 2013-03-13 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD (P980016/S396) | Medtronic Cardiac Rhythm Disease Management | 2013-03-13 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S039) | Medtronic, Inc. | 2013-03-13 |
| INSYNC III (MODEL 9981 V8.0) (P010015/S166) | Medtronic, Inc. | 2013-03-13 |
| CONSULTA DF4 ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S359) | Medtronic Cardiac Rhythm Disease Management | 2013-03-13 |
| KAPPA 900 (MODEL 9988 V8.0). ADAPTA, VERSA, SENSIA (MODEL SW003 V8.0), RELIA (MODEL SW010 V8.0), ENPULSE (MODEL 9981 V8. (P980035/S280) | Medtronic, Inc. | 2013-03-13 |
| REPLY AND ESPIRIT FAMILY OF PACEMAKERS (P950029/S075) | MicroPort CRM USA, Inc. | 2013-03-13 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S039) | Medtronic, Inc. | 2013-03-13 |
| HANCOCK LOW POROSITY AND MOFIFIED ORIFICE VALVED CONDUIT (P790007/S035) | Medtronic Heart Valves | 2013-03-13 |
| DEVICE CARELINK ENCORE 29901 PROGRAMMER INCLUDING ACCESSORIES AND REVEAL DX, REVEAL XT (MODEL SW007 V8.0) (P890003/S254) | Medtronic, Inc. | 2013-03-13 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S047) | Medtronic, Inc. | 2013-03-13 |
| LATITUDE COMMUNICATOR (P910077/S132) | Boston Scientific | 2013-03-13 |
| VISTATRON C&T SERIES (MODEL VSF04 V8.0, MODEL VSF 12 V8.0, MODEL VSF08 V8.0) (P990001/S105) | Medtronic, Inc. | 2013-03-13 |
| CONCERTO, VIRTUOSO (MODEL SW002 V8.0) (P980016/S366) | Medtronic Cardiac Rhythm Disease Management | 2013-03-13 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS (P870056/S057) | Edwards Lifesciences, LLC | 2013-03-12 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S008) | Edwards Lifesciences, LLC | 2013-03-12 |
| REPLY/ESPRIT SR/DR PACEMAKERS (P950029/S074) | MicroPort CRM USA, Inc. | 2013-03-12 |
| INGENIO (MODELS K172, K173, K174) AND ADVANTIO (MODELS K062, K063 AND K 064) PACEMAKERS (N970003/S140) | Boston Scientific Corp | 2013-03-12 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S039) | Edwards Lifesciences, LLC | 2013-03-12 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S041) | Edwards Lifesciences, LLC | 2013-03-12 |
| CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P) MODELS V172 AND V173 (P030005/S088) | Guidant Corp. | 2013-03-12 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINBE MITRAL BIOPROSTHESIS (P870077/S052) | Edwards Lifesciences, LLC | 2013-03-12 |
| CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESES (P860057/S105) | Edwards Lifesciences, LLC | 2013-03-12 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S022) | Edwards Lifesciences, LLC | 2013-03-12 |
| CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDSPERIMOUNT THEON PERCARDIAL AORTIC BIOPRO (P860057/S104) | Edwards Lifesciences, LLC | 2013-03-12 |
| PARADYM AND PARADYM RF CRT-D'S (P060027/S047) | MicroPort CRM USA, Inc. | 2013-03-12 |
| REPLY/ESPRIT PACEMAKERS (P950029/S073) | MicroPort CRM USA, Inc. | 2013-03-12 |
| PARADYM VR/DR AND PARADYM RF VR/DR ICD'S (P980049/S079) | MicroPort CRM USA, Inc. | 2013-03-12 |
| ACUITY SPIRAL LEAD (P010012/S319) | Boston Scientific Corp | 2013-03-08 |
| NAVISTAR®THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER (P040036/S030) | Biosense Webster, Inc. | 2013-03-07 |
| STOCKERT 70 RADIOFREQUENCY GENERATOR (P990071/S017) | Biosense Webster, Inc. | 2013-03-07 |
| BRAVIA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S358) | Medtronic Cardiac Rhythm Disease Management | 2013-03-07 |
| CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S002) | Boston Scientific Corporation | 2013-03-07 |
| CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D), PUNTUA CRT-D, COOGINS, ENERGEN CRT-D, INCEPTA CRT-D (P010012/S323) | Boston Scientific Corp | 2013-03-07 |
| ADVISA MRI (P980035/S308) | Medtronic, Inc. | 2013-03-07 |
| NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025/S031) | Biosense Webster, Inc. | 2013-03-07 |
| BLACKWELL BATTERY UBITS (UNIVERSAL BURN-IN TEST SYSTEM) (P010031/S354) | Medtronic Cardiac Rhythm Disease Management | 2013-03-07 |
| PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBTILLATOR, TELIGEN IMPLANTABLE CARIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARDI (P960040/S288) | Boston Scientific | 2013-03-07 |
| PUNCTUA CRT-D, COGNIS CRT-D, ENERGEN CRT-D, INCEPTA CRT-D (P010012/S322) | Boston Scientific Corp | 2013-03-07 |
| BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S357) | Medtronic Cardiac Rhythm Disease Management | 2013-03-07 |
| NAVISTAR® THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER AND CELSIUS® THERMOCOOL® DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P030031/S041) | Biosense Webster, Inc. | 2013-03-07 |
| CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P950005/S037) | Biosense Webster, Inc. | 2013-03-07 |
| NAVISTAR® AND CELSIUS® DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P010068/S027) | Biosense Webster, Inc. | 2013-03-07 |
| PUNCTUA ICD, TELIGEN ICD, ENERGEN ICD, INCEPTA ICD (P960040/S287) | Boston Scientific | 2013-03-07 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S353) | Medtronic Cardiac Rhythm Disease Management | 2013-03-05 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STEN SYSTEM (P110010/S048) | Boston Scientific Corp | 2013-03-05 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S021) | Boston Scientific Corporation | 2013-03-05 |
| ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S070) | Boston Scientific Corp | 2013-03-05 |
| BRAVA/VIVA S/VIVA XT CRT-D (P010031/S356) | Medtronic Cardiac Rhythm Disease Management | 2013-03-05 |
| CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S013) | Boston Scientific Corp | 2013-03-05 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S005) | Medtronic | 2013-03-04 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S004) | Cook Ireland, Ltd. | 2013-03-01 |
| ARTERX SURGICAL SEALANT (P100030) | Baxter Healthcare Corporation | 2013-03-01 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S349) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTO/PROTECTO XT/SECURA/VIRTUOSO/VIRTUOSO II/PROTECTA XT DR/PROTECTA DR (P980016/S331) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS (P870056/S055) | Edwards Lifesciences, LLC | 2013-02-28 |
| UNIPOLAR/ LEAD END PIN CAP/OVAL PATCH LEAD (P900061/S111) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| ATTAIN/CONSULTA CRT-P/SYNCRA CRT-P (P010015/S148) | Medtronic, Inc. | 2013-02-28 |
| PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT (P890003/S240) | Medtronic, Inc. | 2013-02-28 |
| VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM (P100040/S010) | Medtronic Vascular | 2013-02-28 |
| ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA (P980035/S253) | Medtronic, Inc. | 2013-02-28 |
| LEAD ADAPTOR/SPRINT QUATTRO/ SPRINT QUATTRO LEAD/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD (P920015/S084) | Medtronic, Inc. | 2013-02-28 |
| SELECTSECURE (P030036/S037) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S037) | Edwards Lifesciences, LLC | 2013-02-28 |
| ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S064) | Spectranetics Corp. | 2013-02-28 |
| CASURE/Z NOVUS/ VITATRON IMPULSE II (P850089/S085) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S351) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3TM DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDW (P100041/S018) | Edwards Lifesciences, LLC | 2013-02-28 |
| SELECTSECURE LEAD MODEL 3830 TECHNICAL MANUAL (P030036/S053) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| MEDTRONIC CAPSURE LEAD (P830061/S073) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| SLS SPECTRANETICS LASER SHEATHS (P960042/S046) | Spectranetics (Philips) | 2013-02-28 |
| ATTAIN STARFIX (P060039/S031) | Medtronic, Inc. | 2013-02-28 |
| CARPENTIER-EDWARDS S.A.V AORTIC PORCINE BIOPROSTHESIS (P010041/S039) | Edwards Lifesciences, LLC | 2013-02-28 |
| REVO MRI (P090013/S047) | Medtronic, Inc. | 2013-02-28 |
| CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE (P870077/S050) | Edwards Lifesciences, LLC | 2013-02-28 |
| TRANSVENE CS/SVC LEAD (P980050/S068) | Medtronic, Inc. | 2013-02-28 |
| CARPENTIER-EDWARDS PERIMOUNT FAMILY OF PERICARDIAL BIOPROSTHESES (P860057/S098) | Edwards Lifesciences, LLC | 2013-02-28 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S038) | Medtronic, Inc. | 2013-02-28 |
| D286 CURRENT DRAIN LIMITS (P010031/S348) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| CONCERTO/CONCERTO II/INSYNC III MARQUIS/ INSYNC MAXIMO/MAXIMOII/PROTECTA/PROTECTA XT/PROTECTA CRT-D (P010031/S284) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDWAR (P110021/S003) | Edwards Lifesciences, LLC | 2013-02-28 |
| ATTAIN ABILITY/ATTAIN ABILITY PLUS/ATTAIN ABILITY STRAIGHT (P080006/S036) | Medtronic, Inc. | 2013-02-28 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S355) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| BRAVA CRT-D, VIVA S CRT-D AND VIVA XT CRT-D (P010031/S352) | Medtronic Cardiac Rhythm Disease Management | 2013-02-28 |
| CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIC (P930039/S064) | Medtronic, Inc. | 2013-02-28 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S013) | Medtronic | 2013-02-27 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S188) | Medtronic, Inc. | 2013-02-27 |
| PROTEGE GPS/RX CAROTID STENT SYSTEMS (P060001/S019) | Medtronic Vascular, Inc. | 2013-02-27 |
| ADVISA DR IPG, ADVISA MRI IPG (P980035/S306) | Medtronic, Inc. | 2013-02-27 |
| ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG (P980035/S305) | Medtronic, Inc. | 2013-02-26 |