PMA P150004S083

Device: Proclaim™ Dorsal Root Ganglion (DRG) IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S083
Product code: PMP
Decision date: 2025-02-21
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: to qualify an additional production line at a new manufacturing site in Huizhou, China, for the purposes of completing the backend processing of resistors used in the hybrid component of Abbott’s Orion and Gemini implantable pulse generators

Current openFDA PMA Record#

Device: Proclaim™ Dorsal Root Ganglion (DRG) IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S083
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2025-02-21
Decision code: OK30
Date received: 2025-02-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to qualify an additional production line at a new manufacturing site in Huizhou, China, for the purposes of completing the backend processing of resistors used in the hybrid component of Abbott’s Orion and Gemini implantable pulse generators