PMA P010032S250

Device: Proclaim™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG); Eterna™ SCS IPG
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S250
Product code: LGW
Decision date: 2026-04-30
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: approval to qualify an alternate second-tier supplier to provide drop-in replacements of the battery fill plug subcomponent on behalf of an Abbott’s first tier supplier

Current openFDA PMA Record#

Device: Proclaim™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG); Eterna™ SCS IPG
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S250
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-04-30
Decision code: OK30
Date received: 2026-03-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to qualify an alternate second-tier supplier to provide drop-in replacements of the battery fill plug subcomponent on behalf of an Abbott’s first tier supplier