PMA P010032S245

Device: 8-channel adapter, M, 10cm; 8-channel adapter, M, 60cm; 8-channel adapter, B, 10cm; 8-channel adapter, B, 60cm; Legacy M
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S245
Product code: LGW
Decision date: 2026-02-11
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Introduction of the manufacturing aid and stabilizer phosphoric acid to the Bionate raw material (55D PCU, 55D IMG, and 75D)

Current openFDA PMA Record#

Device: 8-channel adapter, M, 10cm; 8-channel adapter, M, 60cm; 8-channel adapter, B, 10cm; 8-channel adapter, B, 60cm; Legacy M
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S245
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-02-11
Decision code: APPR
Date received: 2025-11-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Introduction of the manufacturing aid and stabilizer phosphoric acid to the Bionate raw material (55D PCU, 55D IMG, and 75D)