PMA P150004S081

Device: Axium Neurostimulator System
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S081
Product code: PMP
Decision date: 2024-12-13
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: qualification of a third-tier alternate supplier to provide 35N-LT alloy tubing and ASTM B413 99.99% silver raw material for the leads, extensions, and adaptors

Current openFDA PMA Record#

Device: Axium Neurostimulator System
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S081
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2024-12-13
Decision code: OK30
Date received: 2024-11-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: qualification of a third-tier alternate supplier to provide 35N-LT alloy tubing and ASTM B413 99.99% silver raw material for the leads, extensions, and adaptors