PMA P150004S093

Device: Proclaim™ Doral Root Ganglion (DRG) IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S093
Product code: PMP
Decision date: 2026-03-13
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: approval to consolidate manufacturing activities from two manufacturing facilities into a single manufacturing facility and to utilize new equipment at the consolidated manufacturing facility

Current openFDA PMA Record#

Device: Proclaim™ Doral Root Ganglion (DRG) IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S093
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2026-03-13
Decision code: OK30
Date received: 2026-02-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to consolidate manufacturing activities from two manufacturing facilities into a single manufacturing facility and to utilize new equipment at the consolidated manufacturing facility