PMA P150004S065

Device: DRG System - Leads and Extensions
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S065
Product code: PMP
Decision date: 2024-01-22
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: for the qualification of alternate resin supplier manufacturing site, supplier process changes associated with the alternate resin manufacturing site, and the utilization of an alternate supplier for raw material used to manufacture the resin.

Current openFDA PMA Record#

Device: DRG System - Leads and Extensions
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S065
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2024-01-22
Decision code: APPR
Date received: 2023-08-08
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for the qualification of alternate resin supplier manufacturing site, supplier process changes associated with the alternate resin manufacturing site, and the utilization of an alternate supplier for raw material used to manufacture the resin.