PMA P150004S086

Device: Proclaim DRG IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S086
Product code: PMP
Decision date: 2025-07-02
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: approval for the relocation of the flange subcomponent manufacturing process and associated milling equipment from Integer's facility in Brooklyn Park, Minnesota, USA to Integer's facility in Tijuana North, Mexico

Current openFDA PMA Record#

Device: Proclaim DRG IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S086
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2025-07-02
Decision code: OK30
Date received: 2025-06-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the relocation of the flange subcomponent manufacturing process and associated milling equipment from Integer's facility in Brooklyn Park, Minnesota, USA to Integer's facility in Tijuana North, Mexico