PMA P010032

Device: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S194
Product code: LGW
Decision date: 2026-05-26
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for the replacement of existing manufacturing equipment (LS-5) with new equipment (LS-6), for internal supplier Abbott Portland.

Current openFDA PMA Record#

Device: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S252
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-05-26
Decision code: OK30
Date received: 2026-04-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the replacement of existing manufacturing equipment (LS-5) with new equipment (LS-6), for internal supplier Abbott Portland.