| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S035) | ABBOTT MEDICAL | 2014-05-06 |
| THERAPY COOL PATH DUO CATHETER (12 HOLE IRRIGATED), SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED), COOL PATH DUO ABLATION C (P110016/S011) | ABBOTT MEDICAL | 2014-04-28 |
| EON MINI IPG NEUROSTIMULATION SYSTEM (P010032/S073) | ABBOTT MEDICAL | 2014-04-25 |
| EON CTM IPG NEUROSTIMULATION SYSTEM (P010032/S076) | ABBOTT MEDICAL | 2014-04-25 |
| ASSURITY, ASSURITY +, AND ENDURITY OF PACEMAKER DEVICES (P880086/S241) | ABBOTT MEDICAL | 2014-04-24 |
| ALLURE AND ALLURE QUADRA FAMILIES OF CRT-P DEVICES (P030035/S119) | ABBOTT MEDICAL | 2014-04-24 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S050) | ABBOTT MEDICAL | 2014-04-10 |
| FRONTIER/ FRONTIER II /ANTHEM FAMILY OF CRT-P'S (P030035/S098) | ABBOTT MEDICAL | 2014-04-10 |
| EPIC HF/ATLAS + HF/QUANDRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S226) | ABBOTT MEDICAL | 2014-04-10 |
| CADENCE/ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S (P910023/S297) | ABBOTT MEDICAL | 2014-04-10 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S220) | ABBOTT MEDICAL | 2014-04-10 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS (P060040/S034) | ABBOTT MEDICAL | 2014-04-09 |
| ASSURITY, ASSURITY+ AND ENDURITY FAMILIES OF PACEMAKER DEVICES (P880086/S240) | ABBOTT MEDICAL | 2014-04-04 |
| TRIPOLE 16 AND TRIPOLE 16C LEADS, EXCLAIM LEADS, LAMITRODE 4, LAMITRODE 44, LAMITRODE 44C LEADS, LAMITRODE 88 LEAD (P010032/S077) | ABBOTT MEDICAL | 2014-04-04 |
| ALLURE AND ALLURE QUADRA FAMILIES OF CRT-P DEVICES (P030035/S118) | ABBOTT MEDICAL | 2014-04-04 |
| HEARTMATE II LVAS (P060040/S033) | ABBOTT MEDICAL | 2014-04-03 |
| BIOCOR AND EPIC VALVE (P040021/S025) | ABBOTT MEDICAL | 2014-04-02 |
| REGENT/STANDARD/MASTERS MECHANICAL HEART VALVES (P810002/S089) | ABBOTT MEDICAL | 2014-03-31 |
| PROMOTE,QUADRA ASSURA,UNIFY,UNIFY ASSURA,UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S259) | ABBOTT MEDICAL | 2014-03-31 |
| IDENTITY,SUSTAINXL,VERITY,VICTORY,ZEPHYR,ACCENT FAMILIES OF PACEMAKER DEVICES (P880086/S238) | ABBOTT MEDICAL | 2014-03-31 |
| CURRENT,FORTIFY,FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S328) | ABBOTT MEDICAL | 2014-03-31 |
| ANTHEM FAMILY OF CRT-P DEVICES (P030035/S116) | ABBOTT MEDICAL | 2014-03-31 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S030) | ABBOTT MEDICAL | 2014-03-28 |
| THERAPY COOL PATH DUO CATHETER(12 HOLE IRRIGATED),SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED),COOL PATH DUO ABLATION (P110016/S010) | ABBOTT MEDICAL | 2014-03-21 |
| PROTEGE SYSTEM (P010032/S074) | ABBOTT MEDICAL | 2014-03-21 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S108) | ABBOTT MEDICAL | 2014-03-20 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S230) | ABBOTT MEDICAL | 2014-03-20 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S055) | ABBOTT MEDICAL | 2014-03-20 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S241) | ABBOTT MEDICAL | 2014-03-20 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S311) | ABBOTT MEDICAL | 2014-03-20 |
| THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS) (P060040/S032) | ABBOTT MEDICAL | 2014-03-18 |
| CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S332) | ABBOTT MEDICAL | 2014-03-06 |
| PROMOTE, PROMOTE ACCEL, PROMOTE Q, PROMOTE QUADRA, PROMOTE+, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUANDRA FAMILIES (P030054/S263) | ABBOTT MEDICAL | 2014-03-06 |
| CURRENT , ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S330) | ABBOTT MEDICAL | 2014-03-04 |
| PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S261) | ABBOTT MEDICAL | 2014-03-04 |
| UNIFY, UNIFY ASSURA, UNIFY QUADRA AND QUADRA ASSURA CRT-D'S (P030054/S260) | ABBOTT MEDICAL | 2014-03-04 |
| ANTHEM FAMILY OF CRT-P DEVICES (P030035/S117) | ABBOTT MEDICAL | 2014-03-04 |
| IDENTITY, SUSTAINXL, VERITY VICTORY ZEPHYR, ACCENT FAMILIES OF PACEMAKER DEVICE (P880086/S239) | ABBOTT MEDICAL | 2014-03-04 |
| FORTIFY, FORTIFY ASSURA AND ELLIPSE ICDS (P910023/S329) | ABBOTT MEDICAL | 2014-03-04 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S057) | ABBOTT MEDICAL | 2014-02-26 |
| AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S237) | ABBOTT MEDICAL | 2014-02-26 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY PF CRT-DS (P030054/S254) | ABBOTT MEDICAL | 2014-02-26 |
| FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-PS (P030035/S115) | ABBOTT MEDICAL | 2014-02-26 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S323) | ABBOTT MEDICAL | 2014-02-26 |
| OPTISURE (P950022/S085) | ABBOTT MEDICAL | 2014-02-21 |
| CURRENT, ELLIPSE, FORTIFY, FORTIFYASSURA FAMILIES OF ICD DEVICES (P910023/S327) | ABBOTT MEDICAL | 2014-02-18 |
| PROMOTE, QUADRA ASSURA, UNITY, UNITY ASSURA, UNIFY QUADRA FAMILIES CRT-D DEVICES (P030054/S258) | ABBOTT MEDICAL | 2014-02-18 |
| FORTIFY, FORTIFY ASSURA, AND ELLIPSE ICD'S (P910023/S325) | ABBOTT MEDICAL | 2014-02-06 |
| UNIFY, UNIFY ASSURA, UNIFY QUADRA AND QUADRA ASSURA CRT-D'S (P030054/S256) | ABBOTT MEDICAL | 2014-02-06 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S002) | ABBOTT MEDICAL | 2014-01-28 |
| REGENT, STANDARD AND MASTERS MECHANICAL HEART VALVE (P810002/S088) | ABBOTT MEDICAL | 2013-12-19 |
| THERAPY COOL FLEX ABLATION CATHETER (P110016/S008) | ABBOTT MEDICAL | 2013-12-18 |
| ELLIPSE FAMILY OF ICDS (P910023/S321) | ABBOTT MEDICAL | 2013-12-17 |
| CURRENT,CURRENT ACCEL,CURRENT +,ELLIPSE,FORTIFY,FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S324) | ABBOTT MEDICAL | 2013-12-17 |
| PROMOTE, PROMOTE ACCEL,PROMOTE Q, PROMOTE QUADRA,PROMOTE+,QUADRA ASSURA,UNIFY,UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S255) | ABBOTT MEDICAL | 2013-12-17 |
| ACCENT DR, ACCENT DR RF, ACCENT SR, ACCENT SR RF PACEMAKERS (P880086/S236) | ABBOTT MEDICAL | 2013-12-04 |
| ANTHEM & ANTHEM RF CRT-P'S (P030035/S114) | ABBOTT MEDICAL | 2013-12-04 |
| UNIFY AND UNIFY QUADRA CRT-D'S (P030054/S253) | ABBOTT MEDICAL | 2013-11-26 |
| FORTIFY VR/DR ICD'S (P910023/S322) | ABBOTT MEDICAL | 2013-11-26 |
| 1258T AND 1458Q FAMILY OF LEADS (P030054/S246) | ABBOTT MEDICAL | 2013-11-14 |
| AMPLATZER DUCT OCCLUDER II (P020024/S040) | ABBOTT MEDICAL | 2013-11-08 |
| TRIFECTA VALVE (P100029/S016) | ABBOTT MEDICAL | 2013-11-07 |
| BIOCOR/EPIC VALVE (P040021/S024) | ABBOTT MEDICAL | 2013-11-07 |
| MITRACLIP DELIVERY SYSTEM (P100009) | ABBOTT MEDICAL | 2013-10-24 |
| 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 |
| ACCENT PACEMAKERS (P880086/S235) | ABBOTT MEDICAL | 2013-10-02 |
| TENDRIL AND OPTISENSE FAMILY OF LEADS (P960013/S076) | ABBOTT MEDICAL | 2013-10-02 |
| ISOFLEX FAMILY OF LEADS (1944,1948) (P960030/S038) | ABBOTT MEDICAL | 2013-10-02 |
| ANTHEM CRT-PS (P030035/S113) | ABBOTT MEDICAL | 2013-10-02 |
| THERAPY COOL PATH DUO AND SAFIRE BLU DUO ABLATION CATHETERS (P110016/S009) | ABBOTT MEDICAL | 2013-09-27 |
| HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S028) | ABBOTT MEDICAL | 2013-09-25 |
| ANTHEM RF CRT-PS (P030035/S112) | ABBOTT MEDICAL | 2013-09-05 |
| ACCENT DR RF,ACCENT SR RF PACEMAKER DEVICES (P880086/S234) | ABBOTT MEDICAL | 2013-09-05 |
| SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED AND VERISENSE SYSTEM AND IBI 1500T9-CP V1.6 CARDIAC (P110016/S007) | ABBOTT MEDICAL | 2013-08-29 |
| ICD DEVICES (P910023/S320) | ABBOTT MEDICAL | 2013-08-28 |
| CRT- D DEVICES (P030054/S252) | ABBOTT MEDICAL | 2013-08-28 |
| REGENT MECHANICAL HEART VALVE (P810002/S084) | ABBOTT MEDICAL | 2013-08-19 |
| AMPLATZER DUCT OCCLUDER II (P020024/S037) | ABBOTT MEDICAL | 2013-08-18 |
| SCS ACCESSORY KIT (P010032/S071) | ABBOTT MEDICAL | 2013-08-15 |
| REGENT, STANDARD, AND MASTERS MECHANICAL HEART VALVE (P810002/S087) | ABBOTT MEDICAL | 2013-08-08 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S029) | ABBOTT MEDICAL | 2013-08-05 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER (P110016/S003) | ABBOTT MEDICAL | 2013-07-30 |
| AMPLATZER DUCT OCCLUDER (P020024/S039) | ABBOTT MEDICAL | 2013-07-26 |
| AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER-CRIBRIFORM (P000039/S049) | ABBOTT MEDICAL | 2013-07-26 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S023) | ABBOTT MEDICAL | 2013-07-26 |
| EONC 16-CHANNEL IPG NEUROSTIMULATION SYSTEM (P010032/S072) | ABBOTT MEDICAL | 2013-07-12 |
| ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S086) | ABBOTT MEDICAL | 2013-06-28 |
| GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S050) | ABBOTT MEDICAL | 2013-06-26 |
| FORTIFY AND PROMOTE QUANDRA FAMILY OF ICDS (P910023/S316) | ABBOTT MEDICAL | 2013-06-12 |
| UNIFY AND UNIFY QUANDRA FAMILY OF CRT-DS (P030054/S248) | ABBOTT MEDICAL | 2013-06-12 |
| FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICDS (P910023/S318) | ABBOTT MEDICAL | 2013-06-12 |
| UNIFY, UNIFY ASSURA, QUADRA ASSURA FAMILY OF CRT-D'S (P030054/S250) | ABBOTT MEDICAL | 2013-06-12 |
| CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILIES OF ICD DEVICES (P910023/S319) | ABBOTT MEDICAL | 2013-06-11 |
| PROMOTE+, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY QUADRA, QUADRA ASSURA FAMI LIES OF CRT-D DEVICES (P030054/S251) | ABBOTT MEDICAL | 2013-06-11 |
| 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 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S229) | ABBOTT MEDICAL | 2013-06-06 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S107) | ABBOTT MEDICAL | 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 |