FDA Registration
Active
🇺🇸 United States
SCS Charging System (model 36700)
Reg #: 1627487
·
FEI: 1627487
·
Expires 2025
Products
3
Proprietary Names
102
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Abbott Medical
- Registration Number
- 1627487
- FEI Number
- 1627487
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6901 Preston Rd
- City
- PLANO
- State
- TX
- ZIP
- 75024
- Country
- US
Regulatory Submissions
- PMA Number
- P010032
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | QRB | Class 3 | Unknown | No | 2007-11-30 |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | Class 2 | Neurology | No | 2007-11-30 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2007-11-30 |
Proprietary Names
SCS Charging System (model 36700)
Proclaim 5 IPG (Model 3665)
BurstDR stimulation temp evaluation patient programmer (Model 3857)
Charger Accessories Kit, lumbar (model 36000)
Octrode Lead, 8 electrode, 3/4mm, 90cm (Model 3189)
Proclaim Plus 5 (Medtronic header) (Model 3671)
Port Plug Accessory kit (Model 1108)
Quattrode Lead, 4 electrode, 3/4mm, 90cm (Model 3149)
Stylet, Straight, 30cm (Model 1121)
Eon LE Mobile Charger (Model 3726)
EPG Non-Adhesive Pouch (Model 1214)
Lead Anchor, Butterfly (Model 1105)
NeuroSphere Patient Controller (model 55500)
C-Series Lamitrode Leads (Models 3245)
Proclaim 5 IPG (Medtronic header) (Model 3661)
8-Channel Adapter (Model 2311, 2316)
Stylet, Bent, 30cm (Model 1122)
Genesis Programmer (Model 3850)
Protege IPG (Model 3789)
Stylet, Bent, 90cm (Model 1126)
Proclaim Plus 7 (Medtronic header) (Model 3673)
Tripole 16 Lamitrode (Model 3219)
Lead Instertion Tool (Model 1803)
Charger (model 16000)
8-Channel Adapter, B, 60cm (Model 2326)
Stylet, Straight, 90cm(Model 1125)
Torque Wrench (Model 1101)
S-Series Lamitrode Leads (Models 3243, 3283, 3246, 3286)
Prodigy patient programmer (Model 3855)
Extension, 60cm (Model 3386)
Proclaim 7 Elite IPG (Model 3662)
Extension, 30cm (Model 3383)
Patient Wand (Model 1232)
Tripole 16C Lamitrode Lead (Model 3214)
Lead and Extensions Insertion Tool (Model 1803)
Penta Lead (Model 3228)
Cinch Lead Anchor (Model 1194)
Lamitrode 4 Surgical Lead Kit, 60cm (Model 3240)
Eon Mini Charging System (Model 3722)
External Pulse Generator (EPG) (Model 3599)
Guide Wire for Percutaneous Leads (Model 1102)
Eterna SCS IPG (model 32400)
8-Channel Adapter, B, 10cm (Model 2321)
Port Plug (model 12710)
Prodigy Charger (Model 3730)
SCS EPG 2-Port Header (Model 3032)
Stylet, Bent, 60cm (Model 1124)
NeuroSphere Clinician Programmer (model 55600)
Lamitrode 44 Surgical Lead Kit, 60cm (Model 3244)
Swift-Lock Anchor (Model 1192)
Proclaim 5 Elite IPG (Model 3660)
Charging Apparel, lumbar (model 16750)
Power Supply, Portable Charger (Model 3713)
MTS joining sleeve (Model 1627)
Introde-AK Lead Introducer (Model 1103)
Dual Extension (Models 3341, 3343, 3346)
Eon Charging System (Model 3726)
Quattrode Percutaneous Lead Kit, 30cm, 3/6 Spacing (Model 3153)
Patient manual and magnet (Model 3884)
Lamitrode Percuatenous , 8 electrode, 90cm (Model 3268)
Protege MRI IPG (Model 3771)
Stylet, Straight, 60cm (Model 1123)
Rapid Programmer (Model 3834)
St. Jude Medical Patient Controller (Model 3875)
Octrode Percutaneous Lead Kit, 30cm (Model 3183)
Lead Anchor, Long (Model 1106)
SCS EPG 2-Port Header (model 3042)
Quattrode Percutaneous Lead Kit, 60cm, 3/4 Spacing (Model 3146)
Battery pack (Model 1254)
Pouch, Portable Charger (Model 7241)
Eon Patient Programmer (Model 3851)
Proclaim 7 IPG (Model 3667)
IRDA communication cable (Model 1280)
Charger (Model 3721)
Strain Relief (Model 1109)
Quattrode Lead, 4 electrode, 3/6mm, 90cm (Model 3159)
Charger Accessory (Eon Mini LE) (Model 3720)
Lamitrode® 88 Lead Kit, 60cm Length (Model 3288)
Power Cord, Portable Charger (Model 3714)
Quattrode Percutaneous Lead Kit, 60cm, 3/6 Spacing (Model 3156)
Octrode Percutaneous Lead Kit, 60cm (Model 3186)
Prodigy MRI patient programmer (Model 3856)
Protege MRI patient programmer (Model 3853)
St. Jude Medical Clinician Programmer (Model 3874)
Eon Mini (Model 3788)
A127 Lead Extension
Patient Magnet (Model 1210)
Charger Antenna 36" (Model 3732)
Charging Apparel, pectoral (model 16760)
EonC (Model 3688)
Quattrode Percutaneous Lead Kit, 30cm, 3/4 Spacing (Model 3143)
Proclaim Plus 5 (Model 3670)
Proclaim 7 IPG (Medtronic header) (Model 3663)
Eon Charger, Antenna (Model 3728)
SCS Accessory Kit Sterile (Model 1701)
Power adapter, rapid programmer (Model 1622)
Port Plug Accessory Kit (Model 1111)
Proclaim Plus 7 (Model 3672)
Quattrode® Trial Lead Wide Spaced (Model 3066)
TriCentrus, 16 Lead 60cm Length (Model 3292)
Patient Programmer (Model 3852)
NeuroSphere Digital Health App (3876)
Establishment Types
Manufacture Medical Device