| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S057) | ABBOTT MEDICAL | 2016-05-24 |
| CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+, FAMILY OF ICDS (P910023/S362) | ABBOTT MEDICAL | 2016-05-12 |
| ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY PACEMAKERS (P880086/S261) | ABBOTT MEDICAL | 2016-05-12 |
| PROMOTE/+/RF/Q,PROMOTE ACCEL,PROMOTE QUADRA,UNIFY,UNIFY ASSURA,UNIFY QUADRA,QUADRA ASSURA,EPIC+/HF/HF+/IIHF/II+HF,ATLAS+ (P030054/S292) | ABBOTT MEDICAL | 2016-05-12 |
| ANTHEM, ALLURE/RF, QUADRA ALLURE/RF FAMILY OF CRT-PS (P030035/S139) | ABBOTT MEDICAL | 2016-05-12 |
| MITRACLIP NT CLIP DELIVERY SYSTEM (P100009/S015) | ABBOTT MEDICAL | 2016-05-10 |
| THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039/S055) | ABBOTT MEDICAL | 2016-05-04 |
| AMPLATZER MULTI-FENESTRATED SEPTAL OCCULDER (CRIBRIFORM) (P020024/S045) | ABBOTT MEDICAL | 2016-05-04 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S028) | ABBOTT MEDICAL | 2016-05-04 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S008) | ABBOTT MEDICAL | 2016-05-02 |
| Durata and Optisure HV leads (P950022/S092) | ABBOTT MEDICAL | 2016-05-01 |
| IsoFlex Optim LV leads (P960030/S044) | ABBOTT MEDICAL | 2016-05-01 |
| QuickFlex u and Quartet CRT leads (P030054/S303) | ABBOTT MEDICAL | 2016-05-01 |
| Tendril SDX, ST, STS and OptiSense LV leads (P960013/S081) | ABBOTT MEDICAL | 2016-05-01 |
| GENESIS EON,EONC,EON MINI,PROTEGE,PROTEGE MRI,AND PROCLAIM FAMILY SPINAL CORD STIMULATION (SCS) SYSTEMS (P010032/S100) | ABBOTT MEDICAL | 2016-04-29 |
| CARDIOMEMS (P100045/S006) | ABBOTT MEDICAL | 2016-04-29 |
| AMPLATZER SEPTAL OCCLUDER,CRIBRIFORM OCLUDER,AND DELIVERY AND EXCHANGE SYSTEMS (P000039/S052) | ABBOTT MEDICAL | 2016-04-29 |
| BRIO FAMILY DEEP BRAIN STIMULATION (DBS) SYSTEMS (P140009/S004) | ABBOTT MEDICAL | 2016-04-29 |
| GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S116) | ABBOTT MEDICAL | 2016-04-29 |
| THERAPY COOL PATH DUO ABLATION, THERAPY COOL PATH SP ABLATION CATHETER,SAFIRE BLU DUO ABLATION CATHETER,SAFIRE BLU DUO S (P110016/S021) | ABBOTT MEDICAL | 2016-04-29 |
| AMPLATZER DUCT OCCLUDER AND DELIVERY AND EXCHANGE SYSTEMS (P020024/S041) | ABBOTT MEDICAL | 2016-04-29 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S024) | ABBOTT MEDICAL | 2016-04-29 |
| Tendril ST 1888/1882 TC; Tendril STS 2088 TC; Optisense 1999 (P960013/S080) | ABBOTT MEDICAL | 2016-04-28 |
| VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX (P880086/S263) | ABBOTT MEDICAL | 2016-04-28 |
| ISOFLEX OPTIM (P960030/S040) | ABBOTT MEDICAL | 2016-04-28 |
| ANTHEM, ALLURE, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF (P030035/S141) | ABBOTT MEDICAL | 2016-04-28 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S055) | ABBOTT MEDICAL | 2016-04-28 |
| DURATA, DURATA, OPTISURE (P950022/S089) | ABBOTT MEDICAL | 2016-04-28 |
| MICRONY (P970013/S067) | ABBOTT MEDICAL | 2016-04-28 |
| CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE (P910023/S365) | ABBOTT MEDICAL | 2016-04-28 |
| TENDRIL SDX LEAD, TENDRIL ST LEAD, OPTISENSE, TENDRIL STS LEAD (P960013/S078) | ABBOTT MEDICAL | 2016-04-28 |
| IsoFlex 1944, 1948 (P960030/S043) | ABBOTT MEDICAL | 2016-04-28 |
| PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA, QUADRA ASSURA, QUICKFLEX U, QUARTET (P030054/S295) | ABBOTT MEDICAL | 2016-04-28 |
| BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S097) | ABBOTT MEDICAL | 2016-04-27 |
| TRIFECTA VALVE WITH GLIDE TECHNOLOGY (P100029/S021) | ABBOTT MEDICAL | 2016-04-24 |
| Verity 5056, 5156, 5256, 5356, 5456, 5816; Zephyr 5826, 5626; Identity 5286, 5386; Sustain XL PM1134, PM1136, PM2134, PM (P880086/S271) | ABBOTT MEDICAL | 2016-04-22 |
| CURRENT+ ELLIPSE, FORTIFY ASSURA FAMILIES OF THE ICD DEVICES (P910023/S370) | ABBOTT MEDICAL | 2016-04-21 |
| PROMOTE+ QUADRA ASSURA , UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S301) | ABBOTT MEDICAL | 2016-04-21 |
| GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S114) | ABBOTT MEDICAL | 2016-04-20 |
| BRIO NEUROSTIMULATION SYSTEM (P140009/S013) | ABBOTT MEDICAL | 2016-04-20 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S031) | ABBOTT MEDICAL | 2016-04-14 |
| THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039/S054) | ABBOTT MEDICAL | 2016-04-12 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S027) | ABBOTT MEDICAL | 2016-04-12 |
| AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024/S044) | ABBOTT MEDICAL | 2016-04-12 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S030) | ABBOTT MEDICAL | 2016-04-12 |
| AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024/S043) | ABBOTT MEDICAL | 2016-04-12 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S054) | ABBOTT MEDICAL | 2016-04-05 |
| MITRACLIP CLIP DELIVERY SYSTEM (P100009/S016) | ABBOTT MEDICAL | 2016-04-05 |
| MITRACLIP DELIVERY SYSTEM (P100009/S017) | ABBOTT MEDICAL | 2016-03-30 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S053) | ABBOTT MEDICAL | 2016-03-24 |
| EXTERNAL PULSE GENERATOR, 2 PORT HEADER, ADHESIVE POUCH, EPG; NON-ADHESIVE POUCH WITH BELT. (P010032/S110) | ABBOTT MEDICAL | 2016-03-22 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S026) | ABBOTT MEDICAL | 2016-03-18 |
| EXTERNAL PULSE GENERATOR, 16 CHANNEL, EXTERNAL PULSE GENERATOR, 2 PORT HEADER (P010032/S108) | ABBOTT MEDICAL | 2016-03-07 |
| BRIO IMPLANTABLE PULSE GENERATORS (IPGS) (P140009/S012) | ABBOTT MEDICAL | 2016-03-03 |
| EON, EONC, EON MINI, PROTEGE, PROTEGE MRI IMPLANTABLE PULSE GENERATORS (IPGS) (P010032/S113) | ABBOTT MEDICAL | 2016-03-03 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S029) | ABBOTT MEDICAL | 2016-02-29 |
| GENESIS,EON,EON C , EON MINI,PROTEGE, BRIO FAMILIES OF DEVICES (P140009/S011) | ABBOTT MEDICAL | 2016-02-26 |
| GENESIS,EON,EON C , EON MINI,PROTEGE, BRIO FAMILIES OF DEVICES (P010032/S112) | ABBOTT MEDICAL | 2016-02-26 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S053) | ABBOTT MEDICAL | 2016-02-24 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S025) | ABBOTT MEDICAL | 2016-02-24 |
| AMPLATZER DUCT OCCLUDER, AMPLATZER DUCT OCCLUDER II, (P020024/S042) | ABBOTT MEDICAL | 2016-02-24 |
| FLEXABILITY ABLATION CATHETER (P110016/S024) | ABBOTT MEDICAL | 2016-02-24 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S051) | ABBOTT MEDICAL | 2016-02-24 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS), THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P060040/S048) | ABBOTT MEDICAL | 2016-02-22 |
| Ellipse DR Models CD2311-36, CD2311-36Q, CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC; Ellipse VR Models CD1311-36, CD (P910023/S369) | ABBOTT MEDICAL | 2016-02-22 |
| Victory Models 5816, 5810, 5610; Zephyr Models 5820, 5826, 5620, 5626; Accent Models PM1110, PM1210, PM2110, PM2210; As (P880086/S269) | ABBOTT MEDICAL | 2016-02-22 |
| Assurity Models PM1240, PM2240; Assurity+ Models PM1260, PM2260; Endurity Models PM1160, PM2160; Endurity Core Models CD (P880086/S270) | ABBOTT MEDICAL | 2016-02-22 |
| THERAPY COOL PATH DUO,SAFIRE BLU DUO AND COOL PATH DUO,THERAPY COOL PATH DUO SP,SAFIRE BLU DUO SP,THERAY COOL FLEX CATHP (P110016/S027) | ABBOTT MEDICAL | 2016-02-18 |
| THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS) (P060040/S050) | ABBOTT MEDICAL | 2016-02-18 |
| DURATA AND OPTISURE HV LEADS (P950022/S091) | ABBOTT MEDICAL | 2016-02-17 |
| TENDRIL SDX, ST, STS, AND OPTISCIENSE L V LEADS (P960013/S079) | ABBOTT MEDICAL | 2016-02-17 |
| QUICKFLEX U AND QUARTET CRT LEADS (P030054/S298) | ABBOTT MEDICAL | 2016-02-17 |
| IsoFlex Models 1642T, 1646T, 1944, 1948 (P960030/S042) | ABBOTT MEDICAL | 2016-02-17 |
| EON MINI, PROTEGE, IPG PROTEGE 3.01, IPG PROTEGE MRI (P010032/S111) | ABBOTT MEDICAL | 2016-02-17 |
| ISOFLEX OPTIM LV LEADS (P960030/S041) | ABBOTT MEDICAL | 2016-02-17 |
| QuickFlex u Model 1258T (P030054/S299) | ABBOTT MEDICAL | 2016-02-17 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S138) | ABBOTT MEDICAL | 2016-02-12 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S066) | ABBOTT MEDICAL | 2016-02-12 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S291) | ABBOTT MEDICAL | 2016-02-12 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S260) | ABBOTT MEDICAL | 2016-02-12 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S (P910023/S361) | ABBOTT MEDICAL | 2016-02-12 |
| Axium Neurostimulator System (P150004) | ABBOTT MEDICAL | 2016-02-11 |
| PROMOTE+UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILY OF CRT-D DIVICES (P030054/S297) | ABBOTT MEDICAL | 2016-02-08 |
| CURRENT+ FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES (P910023/S367) | ABBOTT MEDICAL | 2016-02-08 |
| ASSURITY AND ENDURITY CORE FAMILY OF PACEMAKERS (P880086/S267) | ABBOTT MEDICAL | 2016-01-30 |
| THORATEC HEARTMATE II VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P060040/S049) | ABBOTT MEDICAL | 2016-01-21 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S047) | ABBOTT MEDICAL | 2016-01-11 |
| OPTISURE FAMILY OF HIGH VOLTAGE LEADS (P950022/S090) | ABBOTT MEDICAL | 2016-01-08 |
| AMPLATZER SEPTAL OCCLUDER (P000039/S051) | ABBOTT MEDICAL | 2016-01-08 |
| ASSURITY, ASSURITY+, ENDURITY, ENDURITY CORE FAMILY OF PACEMAKER DEVICES (P880086/S266) | ABBOTT MEDICAL | 2016-01-04 |
| ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES (P030035/S144) | ABBOTT MEDICAL | 2016-01-04 |
| FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) ; FLEXABILITY ABLATION CATHETER(UNI-DIRECTIONAL) (P110016/S028) | ABBOTT MEDICAL | 2015-12-21 |
| BRIO LE CHARGING SYSTEM (P140009/S005) | ABBOTT MEDICAL | 2015-12-18 |
| EON CHARGING SYSTEM, EON MINI LE CHARGING SYSTEM, PRODIGY CHARGING SYSTEM (P010032/S102) | ABBOTT MEDICAL | 2015-12-18 |
| ANTHEM, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF FAMILY OF CRT-P DEVICES (P030035/S143) | ABBOTT MEDICAL | 2015-12-15 |
| CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILES OF ICD DEVICES (P910023/S366) | ABBOTT MEDICAL | 2015-12-15 |
| VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKERS DEVICES (P880086/S265) | ABBOTT MEDICAL | 2015-12-15 |
| PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S296) | ABBOTT MEDICAL | 2015-12-15 |
| FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) , FLEXABILITY ABLATION CATHETER (UNI-DIRECTIONAL) (P110016/S026) | ABBOTT MEDICAL | 2015-12-11 |
| BRIO IPG (P140009/S009) | ABBOTT MEDICAL | 2015-12-09 |