| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S157) | ABBOTT MEDICAL | 2017-08-23 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/ II HF/ II (P030054/S329) | ABBOTT MEDICAL | 2017-08-23 |
| Assurity, Assurity+, Endurity families of ICD Devices (P880086/S284) | ABBOTT MEDICAL | 2017-08-22 |
| Thoratec, HeartMate II, Ventricular Assist System (P060040/S067) | ABBOTT MEDICAL | 2017-08-17 |
| Endurity, Endurity Core, Assurity, Assurity+ (P880086/S285) | ABBOTT MEDICAL | 2017-08-14 |
| Endurity MRI, Assurity MRI (P140033/S011) | ABBOTT MEDICAL | 2017-08-14 |
| St. Jude Medical Mechanical heart Valves (P810002/S103) | ABBOTT MEDICAL | 2017-08-10 |
| AMPLATZER PFO Occluder (P120021/S004) | ABBOTT MEDICAL | 2017-08-03 |
| CARDIOMEMS HF SYSTEM (P100045/S015) | ABBOTT MEDICAL | 2017-08-03 |
| AMPLATZER Duct Occluder (P020024/S049) | ABBOTT MEDICAL | 2017-08-03 |
| AMPLATZER Septal Defect Occluder (and Cribriform Occluder) (P000039/S058) | ABBOTT MEDICAL | 2017-08-03 |
| AMPLATZER Muscular VSD Occluder (P040040/S031) | ABBOTT MEDICAL | 2017-08-03 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S047) | ABBOTT MEDICAL | 2017-07-27 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033/S009) | ABBOTT MEDICAL | 2017-07-27 |
| Current, Fortify, Fortify Assura (P910023/S387) | ABBOTT MEDICAL | 2017-07-26 |
| Quartet CRT Leads (P950022/S108) | ABBOTT MEDICAL | 2017-07-26 |
| Promote, Unify Quadra, Assura, Quadra Assura (P030054/S331) | ABBOTT MEDICAL | 2017-07-26 |
| Durata and Optisure HV leads (P030054/S330) | ABBOTT MEDICAL | 2017-07-26 |
| DBS Extensions (P140009/S025) | ABBOTT MEDICAL | 2017-07-24 |
| Proclaim Family of Implantable Pulse Generators; St.Jude Medical External Pulse Generator, Clinical Programmer and Patie (P010032/S125) | ABBOTT MEDICAL | 2017-07-21 |
| Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, 44, S-4, S-8, 88, winged, Penta, Quattrode, Octrode, Dual 4, Sin (P010032/S130) | ABBOTT MEDICAL | 2017-07-21 |
| Axium Leads and other accessories (P150004/S005) | ABBOTT MEDICAL | 2017-07-03 |
| HEARTMATE II LVAS (P060040/S065) | ABBOTT MEDICAL | 2017-06-30 |
| Trim Change (P010032/S129) | ABBOTT MEDICAL | 2017-06-28 |
| Axium Neurostimulator System (P150004/S010) | ABBOTT MEDICAL | 2017-06-28 |
| BRIO NEUROSTIMULATION SYSTEM (P140009/S024) | ABBOTT MEDICAL | 2017-06-28 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S059) | ABBOTT MEDICAL | 2017-06-23 |
| MitraClip and MitraClip NT Clip Delivery System (P100009/S024) | ABBOTT MEDICAL | 2017-06-22 |
| Spinal Cord Stimulator External Pulse Generator (P010032/S128) | ABBOTT MEDICAL | 2017-06-21 |
| CardioMEMS HF System (P100045/S017) | ABBOTT MEDICAL | 2017-06-15 |
| CardioMEMS PA Sensor and Delivery Catheter (P100045/S020) | ABBOTT MEDICAL | 2017-06-15 |
| Durata / Optisure ( Passive); / Durata / Optisure (Active) (P950022/S106) | ABBOTT MEDICAL | 2017-06-13 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S045) | ABBOTT MEDICAL | 2017-05-30 |
| Vaisala Environmental Monitoring System (P110016/S044) | ABBOTT MEDICAL | 2017-05-26 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S043) | ABBOTT MEDICAL | 2017-05-22 |
| Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter, Therapy Cool Path Duo SP Ablation Catheter (P110016/S046) | ABBOTT MEDICAL | 2017-05-19 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S019) | ABBOTT MEDICAL | 2017-05-19 |
| MITRACLIP NT CLIP DELIVER SYSTEM (P100009/S021) | ABBOTT MEDICAL | 2017-05-11 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033/S007) | ABBOTT MEDICAL | 2017-05-05 |
| Cadence(R) Tiered Therapy Defribilation System (P910023/S385) | ABBOTT MEDICAL | 2017-05-05 |
| St Jude Medical Epic HF System (P030054/S328) | ABBOTT MEDICAL | 2017-05-05 |
| Anthem And Frontier II CRT-P'S (P030035/S156) | ABBOTT MEDICAL | 2017-05-05 |
| Accent, Identity, Verity, Victory And Zephyr Pacemakers (P880086/S282) | ABBOTT MEDICAL | 2017-05-05 |
| Axium Neurostimulator System (P150004/S009) | ABBOTT MEDICAL | 2017-05-03 |
| Infinity Neurostimulation System (P140009/S023) | ABBOTT MEDICAL | 2017-05-01 |
| MitraClip Delivery System (P100009/S023) | ABBOTT MEDICAL | 2017-04-28 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S041) | ABBOTT MEDICAL | 2017-04-24 |
| FlexAbility Ablation Catheter, Sensor Enabled (Bi-Directional) & FlexAbility Ablation Catheter, Sensor Enabled (Uni-Dire (P110016/S040) | ABBOTT MEDICAL | 2017-04-17 |
| MitraClip NT Clip Delivery System (P100009/S022) | ABBOTT MEDICAL | 2017-04-13 |
| HeartMate II LVAS (P060040/S066) | ABBOTT MEDICAL | 2017-04-11 |
| FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled (P110016/S039) | ABBOTT MEDICAL | 2017-04-10 |
| Trifecta Valve with Glide (P100029/S025) | ABBOTT MEDICAL | 2017-04-03 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet (P030054/S325) | ABBOTT MEDICAL | 2017-03-30 |
| Anthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure MP (P030035/S155) | ABBOTT MEDICAL | 2017-03-30 |
| Current+, Fortify, Fortify Assura, Ellipse, Promote+ (P910023/S383) | ABBOTT MEDICAL | 2017-03-30 |
| Assurity MRI, Endurity MRI, Tendril MRI (P140033/S004) | ABBOTT MEDICAL | 2017-03-30 |
| IsoFlex Optim (P960030/S054) | ABBOTT MEDICAL | 2017-03-30 |
| Durata, Durata, Optisure (P950022/S104) | ABBOTT MEDICAL | 2017-03-30 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, Verity ADx (P880086/S281) | ABBOTT MEDICAL | 2017-03-30 |
| Tendril SDX Lead, Tendril ST Lead, OptiSence, Tendril STS Lead (P960013/S092) | ABBOTT MEDICAL | 2017-03-30 |
| Tendril SDX/ST/STS and optisense leads (LV active) (P960013/S091) | ABBOTT MEDICAL | 2017-03-21 |
| QuickFlex u and Quarlet Leads (CRT) (P030054/S324) | ABBOTT MEDICAL | 2017-03-21 |
| IsoFlex Optim leads (LV Passive) (P960030/S053) | ABBOTT MEDICAL | 2017-03-21 |
| Tendril MRI leads (MRI) (P140033/S003) | ABBOTT MEDICAL | 2017-03-21 |
| Durata and Optisure Leads (HV Active and Passive) (P950022/S103) | ABBOTT MEDICAL | 2017-03-21 |
| QUARTET 1457Q LV LEAD (P030054/S314) | ABBOTT MEDICAL | 2017-03-15 |
| IsoFlex Optim leads (LV Passive) (P960030/S051) | ABBOTT MEDICAL | 2017-03-14 |
| QuickFlex µ and Quartet leads (CRT) (P030054/S322) | ABBOTT MEDICAL | 2017-03-14 |
| Tendril SDX/ST/STS and Optisense leads (LV Active) (P960013/S089) | ABBOTT MEDICAL | 2017-03-14 |
| Durata and Optisure leads (HV Active and Passive) (P950022/S101) | ABBOTT MEDICAL | 2017-03-14 |
| FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled (P110016/S038) | ABBOTT MEDICAL | 2017-03-07 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033/S005) | ABBOTT MEDICAL | 2017-03-06 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S064) | ABBOTT MEDICAL | 2017-03-02 |
| PROMOTE+, UNIFY, UNIFY QUADRA/ASSURA AND QUADRA ASSURA FAMILY OF CRT-DS (P030054/S318) | ABBOTT MEDICAL | 2017-02-24 |
| PM1160, PM1240, PM1260, PM2160, PM2240, PM2260, PM1152, PM2152 (P880086/S278) | ABBOTT MEDICAL | 2017-02-24 |
| AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ ACCENT FAMILY OF PACEMAKERS (P880086/S277) | ABBOTT MEDICAL | 2017-02-24 |
| CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q, CD1257-40, CD1257-40Q, CD2257-40, CD2257-40Q, CD1357-40, CD1357-40C, CD135 (P910023/S380) | ABBOTT MEDICAL | 2017-02-24 |
| CD3231-40, CD3231-40Q, CD3257-40, CD3257-40Q, CD3357-40, CD3357-40C, CD3357-40Q, CD3357-40QC, (P030054/S319) | ABBOTT MEDICAL | 2017-02-24 |
| CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICDS (P910023/S379) | ABBOTT MEDICAL | 2017-02-24 |
| DURATA AND OPTISURE LEADS (HV ACTIVE AND PASSIVE) (P950022/S100) | ABBOTT MEDICAL | 2017-02-24 |
| PM3120, PM3140, PM3222, PM3242, PM3160, PM3262 (P030035/S152) | ABBOTT MEDICAL | 2017-02-24 |
| AMPLATZER DUCT OCCLUDER/DUCT OCCLUDER II (P020024/S047) | ABBOTT MEDICAL | 2017-02-22 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S030) | ABBOTT MEDICAL | 2017-02-22 |
| AMPLATZER PFO OCCLUDER (P120021/S003) | ABBOTT MEDICAL | 2017-02-22 |
| THE AMPLATZER SEPTAL OCCLUDER/AMPLATZER CRIBRIFORM OCCLUDER (P000039/S057) | ABBOTT MEDICAL | 2017-02-22 |
| Tendril MRI (P140033/S001) | ABBOTT MEDICAL | 2017-02-21 |
| DURATA AND OPTISURE LEADS (HV ACTIVE AND PASSIVE) (P950022/S099) | ABBOTT MEDICAL | 2017-02-21 |
| ISOFLEX OPTIM LEADS (LV PASSIVE) (P960030/S050) | ABBOTT MEDICAL | 2017-02-21 |
| TENDRIL SDX/ST/STS AND OPTISENSE LEADS (LV ACTIVE) (P960013/S088) | ABBOTT MEDICAL | 2017-02-21 |
| QUICKFLEX U AND QUARTET LEADS (CRT) (P030054/S317) | ABBOTT MEDICAL | 2017-02-21 |
| FLEXABILITY ABLATION CATHETER, SENSOR ENABLED (P110016/S025) | ABBOTT MEDICAL | 2017-02-17 |
| CARDIOMEMS HF SYSTEM (P100045/S018) | ABBOTT MEDICAL | 2017-02-14 |
| CARDIOMEMS HF SYSTEM (P100045/S014) | ABBOTT MEDICAL | 2017-02-14 |
| AMPLATZER PFO OCCLUDER (P120021/S001) | ABBOTT MEDICAL | 2017-02-06 |
| LGW (P010032/S127) | ABBOTT MEDICAL | 2017-02-03 |
| TRIFECTA VALVE, VALVE WITH GLIDE (P100029/S024) | ABBOTT MEDICAL | 2017-02-03 |
| MHY (P140009/S022) | ABBOTT MEDICAL | 2017-02-03 |
| PMP (P150004/S006) | ABBOTT MEDICAL | 2017-02-03 |
| SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE (P040021/S030) | ABBOTT MEDICAL | 2017-02-03 |
| MASTERS VALVED GRAFT WITH HEMASHIELD GRAFT TECHNOLOGY (P810002/S100) | ABBOTT MEDICAL | 2017-02-02 |