| Implantable Cardioverter Defibrillator (ICD) (P910023/S388) | ABBOTT MEDICAL | 2017-12-19 |
| High Voltage Active Fixation Lead, (P030054/S332) | ABBOTT MEDICAL | 2017-12-19 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) (P950022/S109) | ABBOTT MEDICAL | 2017-12-19 |
| Low Voltage Active Fixation Lead (P140033/S010) | ABBOTT MEDICAL | 2017-12-19 |
| SlimTip DRG Trial Lead Kit, 50cm & 90cm / SlimTip DRG Implant Lead Kit, 50cm & 90cm / DRG Lead Extension Kit. (P150004/S017) | ABBOTT MEDICAL | 2017-12-15 |
| Tendril MRI Leads (P140033/S014) | ABBOTT MEDICAL | 2017-12-12 |
| Unify/ Unify Quadra/ Unify Assura/ Quadra Assura/ Quadra Assura MP (P030054/S342) | ABBOTT MEDICAL | 2017-12-11 |
| Fortify; Fortify Assura (P910023/S398) | ABBOTT MEDICAL | 2017-12-11 |
| Infinity family of DBS IPGs (P140009/S030) | ABBOTT MEDICAL | 2017-12-09 |
| EonC and Eon Mini Neurostimulation System (P010032/S135) | ABBOTT MEDICAL | 2017-12-09 |
| Proclaim Elite family of SCS IPGs (P010032/S134) | ABBOTT MEDICAL | 2017-12-09 |
| Proclaim DRG family of DRG IPGs (P150004/S014) | ABBOTT MEDICAL | 2017-12-09 |
| Axium Clinical and Patient Programmers (P150004/S016) | ABBOTT MEDICAL | 2017-12-08 |
| Fortify Assura , Ellipse (P910023/S397) | ABBOTT MEDICAL | 2017-12-07 |
| Unify/ Unify Quadra/ Unify Assura / Quadra Assura MP (P030054/S341) | ABBOTT MEDICAL | 2017-12-07 |
| Tendril MRI (P140033/S020) | ABBOTT MEDICAL | 2017-12-07 |
| Tendril ST; Tendril STS; Optisense (P960013/S093) | ABBOTT MEDICAL | 2017-12-07 |
| FlexAbility Ablation Catheter/ FlexAbility Ablation Catheter, Sensor Enabled (P110016/S051) | ABBOTT MEDICAL | 2017-11-29 |
| Proclaim DRG Implantable Pulse Generator (P150004/S018) | ABBOTT MEDICAL | 2017-11-28 |
| Proclaim Family of Implantable Pulse Generators (P010032/S138) | ABBOTT MEDICAL | 2017-11-28 |
| Infinity Family of Implantable Pulse Generators (P140009/S032) | ABBOTT MEDICAL | 2017-11-28 |
| Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S027) | ABBOTT MEDICAL | 2017-11-21 |
| Genesis IPG/Eon IPG/Eon C IPG/Eon Mini IPG/Protege IPG/Protege MRI IPG/Prodigy/Prodigy MRI IPG/Proclaim IPG/Port Plug Ac (P010032/S136) | ABBOTT MEDICAL | 2017-11-21 |
| Brio IPG/Infinity IPG (P140009/S031) | ABBOTT MEDICAL | 2017-11-21 |
| SJM Masters Series mechanical heart valve, SJM Regent Valve, SJM Masters Series Aortic Valved Graft with Hemashield Tech (P810002/S105) | ABBOTT MEDICAL | 2017-11-16 |
| Assurity MRI and Endurity MRI family of Pacemakers, (P140033/S017) | ABBOTT MEDICAL | 2017-11-09 |
| Microny family of Pacemakers (P970013/S075) | ABBOTT MEDICAL | 2017-11-09 |
| Anthem, Allure/RF,Allura Quadra/RF family of CRT-Ps (P030035/S162) | ABBOTT MEDICAL | 2017-11-09 |
| Promote/+/RF/Q. Promote Accel, Promote Quadra, Unity, Unity Assura, Unity Quadra, Quadra Assura , Epic+/HF/HF+/ II HF, A (P030054/S340) | ABBOTT MEDICAL | 2017-11-09 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S290) | ABBOTT MEDICAL | 2017-11-09 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+ familyof ICD's (P910023/S396) | ABBOTT MEDICAL | 2017-11-09 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Ellipse (P030054/S339) | ABBOTT MEDICAL | 2017-11-08 |
| Assurity MRI, Endurity MRI (P140033/S016) | ABBOTT MEDICAL | 2017-11-08 |
| 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 |