| Accent, Assurity, Endurity, Verity ADx, Zephyr, Identity ADx, Victory (P880086/S289) | ABBOTT MEDICAL | 2017-11-08 |
| Anthem, Allure/Allure RF, Allure Quadra / Allure Quadra RF, Allure Quadra MP RF (P030035/S161) | ABBOTT MEDICAL | 2017-11-08 |
| Microny (P970013/S074) | ABBOTT MEDICAL | 2017-11-08 |
| Fortify, Fortify Assura, Quadra Assura, Ellipse (P910023/S395) | ABBOTT MEDICAL | 2017-11-08 |
| SJM MRI Activator (P140033/S012) | ABBOTT MEDICAL | 2017-10-30 |
| CardioMEMS HF System (P100045/S026) | ABBOTT MEDICAL | 2017-10-24 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+H (P030054/S320) | ABBOTT MEDICAL | 2017-10-20 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S279) | ABBOTT MEDICAL | 2017-10-20 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic +, Atlas/II/+, Convert/+, Photon (P910023/S382) | ABBOTT MEDICAL | 2017-10-20 |
| Allure Quadra, Quadra Allure MP, Frontier (P030035/S154) | ABBOTT MEDICAL | 2017-10-20 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S381) | ABBOTT MEDICAL | 2017-10-20 |
| Anthem, Allure/RF, Quadra Allure /RF family ofCRT-Ps (P030035/S153) | ABBOTT MEDICAL | 2017-10-20 |
| Assurity, Endurity, Accent, AddVent, Identity, Entity, Paragon III Sustain (P880086/S280) | ABBOTT MEDICAL | 2017-10-20 |
| Merlin Patient Care System Programmer (P030054/S327) | ABBOTT MEDICAL | 2017-10-20 |
| Promote Accel, Promote Quadra, Unify Assura, Quadra Assura, Epic+/HF/HF+/IIHF/II+HF, Atlas +HF/IIHF/II+HF/III+HF (P030054/S321) | ABBOTT MEDICAL | 2017-10-20 |
| Microny SR+ Regency SC+ (P970013/S070) | ABBOTT MEDICAL | 2017-10-20 |
| Fortify / Fortify Assura / Ellipse (P910023/S394) | ABBOTT MEDICAL | 2017-10-18 |
| Unify / Unify Quadra / Unify Assura / Quadra Assura / Quadra Assura MP (P030054/S338) | ABBOTT MEDICAL | 2017-10-18 |
| Durata and Optisure High Voltage Lead (P950022/S110) | ABBOTT MEDICAL | 2017-10-18 |
| Current+ CD1211-36, CD2211-36, CD1211-36Q, CD2211-36Q; Fortify CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q; Fortify Ass (P910023/S393) | ABBOTT MEDICAL | 2017-10-16 |
| Anthem PM3210 NKE; Allure, Allure Quadra PM3120, PM3222, PM3140, PM3242; Quadra Allure MP PM3160, PM3262; (P030035/S160) | ABBOTT MEDICAL | 2017-10-16 |
| Microny 2525T (P970013/S073) | ABBOTT MEDICAL | 2017-10-16 |
| Assurity MRI PM1272, PM2272; Endurity MRI PM1172, PM2172 (P140033/S015) | ABBOTT MEDICAL | 2017-10-16 |
| Victory 5816, 5810, 5610; Zephyr 5820, 5826, 5620, 5626; Accent PM1110, PM1210, PM2110, PM2210; Assurity PM1240, PM2240; (P880086/S288) | ABBOTT MEDICAL | 2017-10-16 |
| Durata and Optisure Family of High Voltage Leads (P950022/S111) | ABBOTT MEDICAL | 2017-10-16 |
| Promote+ CD3211-36, CD3211-36Q; Unify CD3231-40, CD3231-40Q; Unify Quadra CD3249-40, CD3249-40Q; Unify Assura CD3257-40, (P030054/S337) | ABBOTT MEDICAL | 2017-10-16 |
| DRG Lead Extension Kit (P150004/S015) | ABBOTT MEDICAL | 2017-10-13 |
| Thoratec HeartMate II and HeartMate 3 Ventricular Assist System (LVAS) (P160054/S001) | ABBOTT MEDICAL | 2017-10-12 |
| HeartMate 3 Left Ventricular Assist System (P160054/S002) | ABBOTT MEDICAL | 2017-10-12 |
| Thoratec HeartMate II and HeartMate 3 Ventricular Assist System (LVAS) (P060040/S068) | ABBOTT MEDICAL | 2017-10-12 |
| HeartMate II Left Ventricular Assist System (P060040/S069) | ABBOTT MEDICAL | 2017-10-12 |
| St. Jude Medical Infinity DBS System 4CH Lead & 8CH Directional Lead (P140009/S029) | ABBOTT MEDICAL | 2017-10-04 |
| Axium Neurostimulator System (P150004/S008) | ABBOTT MEDICAL | 2017-09-29 |
| FlexAbility Ablation Catheters (Bi & Uni Directional) (P110016/S034) | ABBOTT MEDICAL | 2017-09-29 |
| Fortify, Fortify Assura (P910023/S390) | ABBOTT MEDICAL | 2017-09-26 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S334) | ABBOTT MEDICAL | 2017-09-26 |
| Biocor and Epic Heart Valves (P040021/S032) | ABBOTT MEDICAL | 2017-09-22 |
| AMPLATZER PFO OCCLUDER (P120021/S002) | ABBOTT MEDICAL | 2017-09-22 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033/S006) | ABBOTT MEDICAL | 2017-09-21 |
| ST JUDE MEDICAL EPIC HF SYSTEM (P030054/S326) | ABBOTT MEDICAL | 2017-09-21 |
| AMPLATZER Duct Occluder II (P020024/S048) | ABBOTT MEDICAL | 2017-09-21 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S384) | ABBOTT MEDICAL | 2017-09-21 |
| TVL(TM) LEAD SYSTEM (P950022/S105) | ABBOTT MEDICAL | 2017-09-21 |
| FlexAbility Ablation Catheter & FlexAbility Ablation Catheter, Sensor Enabled (P110016/S049) | ABBOTT MEDICAL | 2017-09-18 |
| Quadra Assura MP CRT-D, Quadra Assura CRT-D, Unify Assura CRT-D, Unify Quadra CRT-D, Promote Quadra CRT-D, Promote Q CRT (P030054/S336) | ABBOTT MEDICAL | 2017-09-11 |
| Endurity MRI ,Assurity MRI Pacemaker (P140033/S013) | ABBOTT MEDICAL | 2017-09-11 |
| Ellipse. Fortify Assura, Fortify, Current Accel, Current+, Current ICDs (P910023/S392) | ABBOTT MEDICAL | 2017-09-11 |
| Quadra Allura MP RF CRT-P. Quadra Allure MP CRT-P, Allura Quadra CRT-P, Anthem RF CRT-P, Frontier II CRT-P Pacemakers (P030035/S159) | ABBOTT MEDICAL | 2017-09-11 |
| Microny Pacemakers (P970013/S072) | ABBOTT MEDICAL | 2017-09-11 |
| Current+, Fortify, Fortify Assura, Ellipse (P910023/S389) | ABBOTT MEDICAL | 2017-09-11 |
| Allure. Allure Quadra (P030035/S158) | ABBOTT MEDICAL | 2017-09-11 |
| Endurity Core, Endurity, Assurity+, Assurity, Sistain, Accent, Zephyr, Victory, Verify ADx XL, Identity Adx, Identity Pa (P880086/S287) | ABBOTT MEDICAL | 2017-09-11 |
| Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, and Quadra Assura MP (P030054/S333) | ABBOTT MEDICAL | 2017-09-11 |
| Assurity, Assurity+, and Endurity (P880086/S286) | ABBOTT MEDICAL | 2017-09-11 |
| Axium Neurostimulator System (P150004/S012) | ABBOTT MEDICAL | 2017-09-06 |
| Cardiomems HF Pressure Measurement System (P100045/S024) | ABBOTT MEDICAL | 2017-09-06 |
| Genesis And Eon Family Neurostimulation (IPG) Systems (P010032/S133) | ABBOTT MEDICAL | 2017-09-06 |
| Brio Neurostimulation System (P140009/S028) | ABBOTT MEDICAL | 2017-09-06 |
| Axium Neurostimulator System (P150004/S007) | ABBOTT MEDICAL | 2017-08-25 |
| Cassette and Cassette Spacer (P150004/S013) | ABBOTT MEDICAL | 2017-08-24 |
| HeartMate 3 Left Ventricular Assist System (P160054) | ABBOTT MEDICAL | 2017-08-23 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S386) | ABBOTT MEDICAL | 2017-08-23 |
| Promote+ / Unify Quadra /Unity Assura/ Quadra Assura / Quadra Assura MP (P030054/S335) | ABBOTT MEDICAL | 2017-08-23 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S283) | ABBOTT MEDICAL | 2017-08-23 |
| Microny family of Pacemakers (P970013/S071) | ABBOTT MEDICAL | 2017-08-23 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S008) | ABBOTT MEDICAL | 2017-08-23 |
| Current+ / Fortify / Fortify Assura / Ellipse. (P910023/S391) | ABBOTT MEDICAL | 2017-08-23 |
| 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 |