| 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 |
| ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S036) | Beckman Coulter, Inc. | 2013-10-17 |
| GORE VIABAHN ENDOPROSTHESIS,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S057) | W. L. Gore & Associates, Inc. | 2013-10-17 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S028) | Ortho-Clinical Diagnostics, 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 |
| BD PREPSTAIN SYSTEM (P970018/S027) | Bd Diagnostic Systems | 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 |
| TRIPOLE 16 AND 16C (C-SERIES) SPINAL CORD STIMULATION LEADS, EXCLAIM SPINAL CORD STIMULATION LEADS, LAMITRODE 4, 44, 44C (P010032/S067) | ABBOTT MEDICAL | 2013-10-15 |
| HBV ASSAY (P080026/S006) | Abbott Molecular, Inc. | 2013-10-15 |
| PRIMEADVANCED SURESCAN MRI NEUROSTIMULATOR,RESTOREULTRA SURESCAN MRI NEUROSTIMULATOR,RESTOREADVANCED SURESCAN MRI NEUROS (P840001/S249) | Medtronic Neuromodulation | 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 |
| GEL-ONE (P080020/S006) | Seikagaku Corp. | 2013-10-11 |
| CARTENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING (P870077/S056) | Edwards Lifesciences, LLC | 2013-10-11 |
| VITAGEL SURGICAL HEMOSTAT (P050044/S021) | Stryker Corp. | 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 |
| ITREL, RESTORE, SYNERGY, (P840001/S252) | Medtronic Neuromodulation | 2013-10-10 |
| RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S248) | Medtronic Neuromodulation | 2013-10-10 |
| CAPSUREFIX MRI LEAD (P090013/S114) | Medtronic, Inc. | 2013-10-10 |
| INTERSTIM THERAPY FOR BOWEL CONTROL (P080025/S055) | Medtronic Neuromodulation | 2013-10-10 |
| ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S180) | Medtronic, Inc. | 2013-10-10 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S049) | Hologic, 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 |
| INTER STIM (P970004/S162) | Medtronic Neuromodulation | 2013-10-10 |
| SPRINT QUATTRO LEAD (P920015/S118) | Medtronic, Inc. | 2013-10-10 |
| ACTIVA, KINETRA, SOLETRA (P960009/S183) | 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 |
| SYNCHROMED DRUG PUMPS (P860004/S195) | 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 |
| CATHETERS, SYNCHROMED, KITS (P860004/S198) | Medtronic, Inc. | 2013-10-10 |
| INTERSTIM IMPLANTABLE NEUROSTIMULATOR (P970004/S159) | Medtronic Neuromodulation | 2013-10-10 |
| INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL (P100027/S011) | Ventana Medical Systems, Inc. | 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 |
| INTER STIM (P080025/S058) | Medtronic Neuromodulation | 2013-10-10 |
| NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, CELSIUS RMT THERMOCOOL (P950005/S046) | Biosense Webster, Inc. | 2013-10-09 |
| COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S011) | Roche Molecular Systems, Inc. | 2013-10-09 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S036) | Roche Molecular Systems, Inc. | 2013-10-09 |
| COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S037) | Roche Molecular Systems, Inc. | 2013-10-09 |
| OPEN PIVOT HEART VALVE (P990046/S036) | Medtronic Ats Medical, Inc. | 2013-10-09 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S046) | Roche Molecular Systems, Inc. | 2013-10-09 |
| THERMOCOOL SF (P040036/S040) | Biosense Webster, Inc. | 2013-10-09 |
| AMPHLIPRE/COBAS TAQMAN HBV TEST (P050028/S036) | Roche Molecular Systems, Inc. | 2013-10-09 |
| COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S045) | Roche Molecular Systems, Inc. | 2013-10-09 |
| ONYX 18LES & ONYX 34 LES (P030004/S008) | Ev3 Neurovascular | 2013-10-09 |
| COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S037) | Roche Molecular Systems, Inc. | 2013-10-09 |
| AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S010) | Roche Molecular Systems, Inc. | 2013-10-09 |
| EZ STEER (P030031/S057) | Biosense Webster, Inc. | 2013-10-09 |
| SALINE-FILLED & SPECTRUM BREAST IMPLANTS (P990075/S022) | Mentor Worldwide, LLC | 2013-10-08 |
| 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 |
| VIRTUOSO DR,VIRTUOSO VR,SECURA DR,MAXIMO II DR,VIRTUOSO II DR,SECURA VR,MAXIMO II VR,VIRTUOSO II VR,PROTECTA XT DR,PROTE (P980016/S431) | Medtronic Cardiac Rhythm Disease Management | 2013-10-07 |
| CHILLI COOLED ABLATION SYSTEM (P980003/S041) | Boston Scientific Corp | 2013-10-07 |
| MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS (P890003/S283) | Medtronic, Inc. | 2013-10-07 |
| EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S060) | Boston Scientific Corp | 2013-10-07 |
| 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,VIVA S,BR (P010031/S392) | Medtronic Cardiac Rhythm Disease Management | 2013-10-07 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S387) | Medtronic Cardiac Rhythm Disease Management | 2013-10-04 |
| GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S032) | W. L. Gore & Associates, Inc. | 2013-10-04 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S426) | Medtronic Cardiac Rhythm Disease Management | 2013-10-04 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S055) | W. L. Gore & Associates, Inc. | 2013-10-04 |
| MULTI-LINK 8 CORONARY STENT SYSTEM (P020047/S054) | Abbott Vascular | 2013-10-04 |
| SPF IMPLANTABLE SPINAL FUSION STIMULATORS (P850035/S036) | Ahp Eos Buyer, Inc. | 2013-10-03 |
| SNS URINARY EXTENSIONS, SNS URINARY LEADS (P970004/S158) | Medtronic Neuromodulation | 2013-10-03 |
| SNS BOWEL EXTENSIONS, SNS BOWEL LEADS (P080025/S054) | Medtronic Neuromodulation | 2013-10-03 |
| EBI OSTEOGEN BONE GROWTH STIMULATORS (P790005/S050) | Ahp Eos Buyer, Inc. | 2013-10-03 |
| ARTIC FRONT CRYOABLATION CATHETER,ARTIC FRONT ADVANCE CRYOABLATION CATHETER (P100010/S026) | Medtronic Cryocath, LP | 2013-10-03 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S014) | OraSure Technologies, Inc. | 2013-10-03 |