PMA P150004S094

Device: Proclaim™ Dorsal Root Ganglion (DRG) IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S094
Product code: PMP
Decision date: 2026-04-30
Classification: Neurology
Generic name: Dorsal root ganglion stimulator 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™ Dorsal Root Ganglion (DRG) IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S094
Product code: PMP
Generic name: Dorsal root ganglion stimulator 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