PMA P150004S089

Device: Proclaim™ Doral Root Ganglion (DRG) IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S089
Product code: PMP
Decision date: 2025-08-29
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: approval for the addition of a fixture which will be utilized in the manufacturing process of the Proclaim SCS, Proclaim DRG and Infinity DBS Implantable Pulse Generators

Current openFDA PMA Record#

Device: Proclaim™ Doral Root Ganglion (DRG) IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S089
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2025-08-29
Decision code: OK30
Date received: 2025-08-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the addition of a fixture which will be utilized in the manufacturing process of the Proclaim SCS, Proclaim DRG and Infinity DBS Implantable Pulse Generators