PMA P010032S255

Device: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S255
Product code: LGW
Decision date: 2026-07-17
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: approval for the shelf-life extension changes of the raw materials used in the manufacture of the SCS and DBS leads, extensions and adapters

Current openFDA PMA Record#

Device: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S255
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-07-17
Decision code: OK30
Date received: 2026-06-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the shelf-life extension changes of the raw materials used in the manufacture of the SCS and DBS leads, extensions and adapters