Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
ABBOTT MEDICAL · Stimulator, spinal-cord, totally implanted for pain relief · Neurology
Open FDA's page for this record- PMA number
- P010032
- Supplement number
- S266
- Applicant
- ABBOTT MEDICAL
- Street 1
- 6901 Preston Rd.
- City
- Plano
- State
- TX
- Zip
- 75024
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Trade name
- Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
- Product code
- LGW
- Advisory committee
- NE
- Advisory committee description
- Neurology
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-09-30
- Decision date
- 2026-10-30
- Decision code
- OK30
- Ao statement
animal-derived to non-animal derived EBS [Ethylene Bis-stearamide] lubricant to be used in TPU [thermoplastic polyurethane] resin production for the BLE [Bluetooth low energy] antenna manufacturing process. This applies specifically to the BLE antenna used in the IPG [implantable pulse generator] for either bundled device; DBS [Deep Brain Stimulator] and SCS [Spinal cord Stimulator]
- Harmonized identifiers (openFDA)
- Device name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 2182291, 2133772, 1627487, 3027063190, 3007882731, 3007616088, 3021836309, 3010052483, 3018094310, 3012693387, 3009380063, 3015200795, 3010326622, 3010086866, 3003335547, 3010966701, 2134604, 9610139, 3003477135, 3003120897, 2135338, 3014507028, 1035166, 3004593495, 3019807891, 2648729, 3020969413, 3038429246, 3006630150, 3013973539, 3008514029, 3010972758, 3004209178, 3005160949, 3016618265, 9616693, 3008988055, 2133810, 2182207, 2030624 +15 more
- FEI number
- 2182291, 1627487, 3027063190, 3007882731, 3000209794, 3021836309, 3000203466, 3007616088, 3010052483, 3018094310, 3012693387, 3009380063, 3015200795, 3010326622, 3010086866, 3003335547, 3010966701, 3000206435, 3003477135, 3003120897, 3014507028, 1035166, 3004593495, 3004369318, 3005846326, 3019807891, 3005700659, 2648729, 3020969413, 3038429246, 3003574398, 3006630150, 3013973539, 3008514029, 3010972758, 3005160949, 3002623849, 3016618265, 3008988055, 3006705815 +15 more