PMA P010032

Device: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S194
Product code: LGW
Decision date: 2026-08-07
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for an alternate solder bumping site and a replacement per- and polyfluoroalkyl substances (PFAS)-free passivation layer material used in production of Bluetooth® (BLE) integrated circuit (IC) Chips at third-tier supplier, Nordic.

Current openFDA PMA Record#

Device: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S254
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-08-07
Decision code: APPR
Date received: 2026-06-08
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an alternate solder bumping site and a replacement per- and polyfluoroalkyl substances (PFAS)-free passivation layer material used in production of Bluetooth® (BLE) integrated circuit (IC) Chips at third-tier supplier, Nordic.