| PRODIGY IPG (P890003/S276) | Medtronic, Inc. | 2013-06-06 |
| BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S) (P950005/S041) | Biosense Webster, Inc. | 2013-06-06 |
| FREEZOR MAX CARDIAC CRYO ABLATION CATHETER (P100010/S027) | Medtronic Cryocath, LP | 2013-06-06 |
| ELLIPSE FAMILY OF ICDS (P910023/S315) | ABBOTT MEDICAL | 2013-06-06 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S238) | ABBOTT MEDICAL | 2013-06-06 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S014) | Boston Scientific Corp | 2013-06-06 |
| WALLSTENT ENDOPROSTHESIS TIPS (P930031/S043) | Boston Scientific Corp | 2013-06-06 |
| FREEZOR CARDIAC CRYO ABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYO ABLATION DEVICE, FREEZOR MAX SURGICAL CARDI (P020045/S047) | Medtronic Cryocath, LP | 2013-06-06 |
| CONTAK RENEWWAL TR INVIVE FAMILIES (P030005/S098) | Guidant Corp. | 2013-06-06 |
| CONFIENT, VIVIAN, INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY FAMILIES. (P960040/S294) | Boston Scientific | 2013-06-06 |
| INCEPTA ENERGEN PUNCTUA COGNIS, LIVIAN FAMILIES (P010012/S329) | Boston Scientific Corp | 2013-06-06 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S229) | ABBOTT MEDICAL | 2013-06-06 |
| WALLSTENT ENDOPROSTHESIS VENOUS (P980033/S032) | Boston Scientific Corporation | 2013-06-06 |
| WALLSTENT ENDOPROSTHESIS ILIAC (P940019/S037) | Boston Scientific Scimed, Inc. | 2013-06-06 |
| ADAPTA,VERSA,SENSIA IPG (P980035/S324) | Medtronic, Inc. | 2013-06-06 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S107) | ABBOTT MEDICAL | 2013-06-06 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S012) | Boston Scientific Corp | 2013-06-06 |
| INSIGNIA, ALTRUA, INGENIO, ADVANTIO FAMILIES (N970003/S151) | Boston Scientific Corp | 2013-06-06 |
| 5846 DISPOSABLE PATIENT CABLE (P820003/S121) | Medtronic Cardiac Rhythm Disease Management | 2013-06-06 |
| MICRONY FAMILY PACEMAKERS (P970013/S054) | ABBOTT MEDICAL | 2013-06-06 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S309) | ABBOTT MEDICAL | 2013-06-06 |
| UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX S) (P010068/S031) | Biosense Webster, Inc. | 2013-06-06 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S051) | W. L. Gore & Associates, Inc. | 2013-06-04 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S026) | ABBOTT MEDICAL | 2013-06-03 |
| BIOCOR/EPIC VALVE (P040021/S023) | ABBOTT MEDICAL | 2013-06-03 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S001) | Cook Ireland, Ltd. | 2013-06-03 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S027) | ABBOTT MEDICAL | 2013-06-03 |
| CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM (P970029/S024) | Cryolife, Inc. | 2013-05-31 |
| EPIC VASCULAR SELF EXPANDING STENT SYSTEM (P110035/S013) | Boston Scientific Corp | 2013-05-31 |
| SYNERGYST II PACING SYSTEM (P890003/S265) | Medtronic, Inc. | 2013-05-30 |
| REGENT MECHANICAL HEART VALVE, STANDARD MECHANICAL HEART VALVE, MASTER MECHANICAL HEART VALVE (P810002/S085) | ABBOTT MEDICAL | 2013-05-30 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S019) | Syncardia Systems, LLC | 2013-05-30 |
| IDENTITY, VERITY, INTEGRITY, VOCTORY, XEPHYR, ACCENT FAMILY OF PACEMAKER DEVICES (P880086/S233) | ABBOTT MEDICAL | 2013-05-30 |
| FRONTIER, FRONTIER II, ANTHEM FAMILY OF CRT-P DEVICES (P030035/S111) | ABBOTT MEDICAL | 2013-05-30 |
| VERSATRAX PACING SYSTEM (P820003/S117) | Medtronic Cardiac Rhythm Disease Management | 2013-05-30 |
| ATTAIN STARFIX LEAD (P060039/S046) | Medtronic, Inc. | 2013-05-29 |
| ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S076) | Medtronic, Inc. | 2013-05-29 |
| TENDRILL STS MODEL 2088TC LEAD (P960013/S075) | ABBOTT MEDICAL | 2013-05-29 |
| 3F AORTIC BIOPROSTHESIS (P060025/S010) | Medtronic, Inc. | 2013-05-29 |
| CAPSURE LEAD (P890003/S275) | Medtronic, Inc. | 2013-05-29 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S032) | Bard Peripheral Vascular | 2013-05-29 |
| KAINOX VCS,LINOX,LINOX SMART,VIGILA,VOLTA (P980023/S055) | Biotronik, Inc. | 2013-05-29 |
| DEXTRUS,ECURO,EFFECTA,ESTELLA,EVIA,ENTOVIS,SELOX,SETROX S,SOLOX,TILDA (P950037/S123) | Biotronik, Inc. | 2013-05-29 |
| EZ STEER BI-DIRECTIONAL NON NAV 4 MM TIP WITH THERMOCOUPLE, 7F EZ NON-NAV CATHETER W/4MM TIP ELECTRODE AND THERMISTOR (P950005/S044) | Biosense Webster, Inc. | 2013-05-29 |
| 7.5 FR NAVI-STAR THERMO-COOL VATHETER WITH THERMISTOR (P040036/S036) | Biosense Webster, Inc. | 2013-05-29 |
| SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE SVC LEAD (P920015/S111) | Medtronic, Inc. | 2013-05-29 |
| CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,VITATRON CRYSTALLINE LEAD,VITATRON PIROUET LEAD (P930039/S088) | Medtronic, Inc. | 2013-05-29 |
| 7F EZ STEER DS BI-DIRECTIONAL NAV CATHETER 4MM TIP ELECTRODE AND THERMOCOUPLE (P990025/S037) | Biosense Webster, Inc. | 2013-05-29 |
| DURATA FAMILY OF HIGH VOLTAGE LEADS (P950022/S086) | ABBOTT MEDICAL | 2013-05-29 |
| ATTAIN BIPOLAR OTW LEAD,LEFT VENTRICULAR PACING LEAD (P010015/S200) | Medtronic, Inc. | 2013-05-29 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S049) | Medtronic, Inc. | 2013-05-29 |
| CELERITY,COROX,ENTOVIS HF(-T),EVIA HF (-T),STRATOS (P070008/S043) | Biotronik, Inc. | 2013-05-29 |
| SELECTSECURE LEAD (P030036/S057) | Medtronic Cardiac Rhythm Disease Management | 2013-05-29 |
| ATTAIN ABILITY LEAD (P080006/S053) | Medtronic, Inc. | 2013-05-29 |
| CAPSUREFIX MRI LEAD (P090013/S097) | Medtronic, Inc. | 2013-05-29 |
| TRANSVENE LEAD (P980050/S083) | Medtronic, Inc. | 2013-05-29 |
| CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,IMPULSE II LEAD (P850089/S097) | Medtronic Cardiac Rhythm Disease Management | 2013-05-29 |
| 7F CELCIUS THERMO-COOL CATHETER WITH THERMOCOUPLEM, 7F CELCIUS THERMOCOOL CATHETER WITH THERMMISTOR (P030031/S052) | Biosense Webster, Inc. | 2013-05-29 |
| ILESTO,IFORIA,LUMAX (P050023/S065) | Biotronik, Inc. | 2013-05-29 |
| CAPSURE LEAD,VITATRON CRYSTALINE LEAD,VITATRON EXCELLENCE PS+LEAD (P830061/S092) | Medtronic Cardiac Rhythm Disease Management | 2013-05-29 |
| 7 FR EZ STEER NAV DS BI-DIRECTIONAL W/ 8MM TIP ELECTRODE W/ DUAL THERMOCOUPLE (P010068/S034) | Biosense Webster, Inc. | 2013-05-29 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S013) | Medtronic Vascular | 2013-05-29 |
| REVO MRI IPG (P090013/S085) | Medtronic, Inc. | 2013-05-24 |
| MYCARELINK PATIENT MONITOR (P890003/S269) | Medtronic, Inc. | 2013-05-24 |
| ADAPTA VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG AND ENPULSE E1 IPG (P980035/S311) | Medtronic, Inc. | 2013-05-24 |
| INSYNC II P ROTECT ICD, INSYNC III MARQUIS ICD, INSYNC MARQUIS ICD, INSYNC MAXIMO ICD (P010031/S363) | Medtronic Cardiac Rhythm Disease Management | 2013-05-24 |
| ENTRUST ICD, INTRINSIC 30 ICD, INTRINSIC ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO VR IC (P980016/S400) | Medtronic Cardiac Rhythm Disease Management | 2013-05-24 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S190) | Medtronic, Inc. | 2013-05-24 |
| CAPSURE SENSE BIPOLAR LEAD (P830061/S091) | Medtronic Cardiac Rhythm Disease Management | 2013-05-23 |
| CAPSUREFIX MRI SURESCAN LEAD (P090013/S096) | Medtronic, Inc. | 2013-05-23 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S143) | Boston Scientific Corp | 2013-05-23 |
| INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER (CRT-P) (P030005/S092) | Guidant Corp. | 2013-05-23 |
| CAPSUREFIX NOVUS LEAD (P930039/S087) | Medtronic, Inc. | 2013-05-23 |
| ROTABLATOR ROTALINK ADVANCER AND ROTALINK PLUS (P900056/S121) | Boston Scientific Corp | 2013-05-23 |
| ADAPTA/VERSA/SENSIA IPG (P980035/S323) | Medtronic, Inc. | 2013-05-23 |
| XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S109) | Abbott Vascular, Inc. | 2013-05-23 |
| RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDWARDS TRANSFEMORAL BALLOON CATHETER, CRIMPER, ASCENDRA BALLOO (P110021/S013) | Edwards Lifesciences, LLC | 2013-05-22 |
| RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLON CATHETER, EDWARDS TRANSFEMORAL BALLON CATHETER, CRIMPER (P100041/S027) | Edwards Lifesciences, LLC | 2013-05-22 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S019) | Medtronic | 2013-05-22 |
| EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR,MAXIMO II,PROTECTA,PROTECTA XT,SECURA,VIRTUOSO II DR/VR ICDS (P980016/S415) | Medtronic Cardiac Rhythm Disease Management | 2013-05-22 |
| COMPLETE SE VASCULAR STENT SYSTEM (P090006/S010) | Medtronic Vascular | 2013-05-22 |
| BRAVA,CONCERTO II,MAXIMO II,PROTECTA,PROTECTA XT,VIVA S,VIVA XT CRTS,CONSULTA ICD (P010031/S375) | Medtronic Cardiac Rhythm Disease Management | 2013-05-22 |
| XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S044) | Abbott Vascular | 2013-05-21 |
| ZENITH TX2 THORACIC ENDOVASCULAR GRAFT (P070016/S007) | William Cook Europe Aps | 2013-05-20 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER - RAPID EXCHANGE (RX), ANGIOSCULPT PTCS SCORING BALLOON CATHETER - EASY EXCHAN (P050018/S018) | Spectranetics Corp. | 2013-05-20 |
| CELERITY,COROX (P070008/S042) | Biotronik, Inc. | 2013-05-17 |
| COROX OTW 75 UP STEROID,COROX OTW 85 UP STEROID (P050023/S064) | Biotronik, Inc. | 2013-05-17 |
| KAINOX VCS,LINOX,LINOX SMART,VIGILA,VOLTA (P980023/S053) | Biotronik, Inc. | 2013-05-17 |
| DEXTRUS,SELOX,SETROX S,SOLOX,TILDA (P950037/S122) | Biotronik, Inc. | 2013-05-17 |
| MYNXCADENCE AND MYNXGRIP VASCULAR DEVICES (P040044/S048) | Cordis US Corporation | 2013-05-17 |
| ADVISA DR IPR, ADVISA DR MRI IPG (P980035/S317) | Medtronic, Inc. | 2013-05-15 |
| ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S069) | Boston Scientific Corp | 2013-05-15 |
| HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S014) | Medtronic | 2013-05-15 |
| REGENCY, SENSLOG AND DIALOG (P880006/S086) | St. Jude Medical, Inc. | 2013-05-14 |
| REVO MRI IPG (P090013/S095) | Medtronic, Inc. | 2013-05-14 |
| MICRONY (P970013/S056) | ABBOTT MEDICAL | 2013-05-14 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) (P110042/S008) | Boston Scientific Corporation | 2013-05-14 |
| ADDVENT, AFFINITY, IDENTITY, VERITY, INTEGRITY, VICTORY, ZEPHYR, ACCENT, TRIOLOGY, SYNCHRONY AND PARAGON (P880086/S232) | ABBOTT MEDICAL | 2013-05-14 |
| CONSULTA CRT-P, SYNCRA CRT-P (P010015/S199) | Medtronic, Inc. | 2013-05-14 |
| FRONTIER, FRONTIER II AND ANTHEM (P030035/S110) | ABBOTT MEDICAL | 2013-05-14 |