PMA P010032S261

Device: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) Charger
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S261
Product code: LGW
Decision date: 2026-09-11
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: approval to utilize an alternate third-tier supplier for the FR-4 material, which is used in the manufacture of the printed circuit boards for the Chargers of the Eterna SCS IPG and Liberta RC DBS IPG

Current openFDA PMA Record#

Device: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) Charger
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S261
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-09-11
Decision code: OK30
Date received: 2026-08-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to utilize an alternate third-tier supplier for the FR-4 material, which is used in the manufacture of the printed circuit boards for the Chargers of the Eterna SCS IPG and Liberta RC DBS IPG