PMA P140009S129

Device: Infinity™ Deep Brain Stimulation (DBS) IPG
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S129
Product code: MHY
Decision date: 2026-03-13
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: approval to consolidate manufacturing activities from two manufacturing facilities into a single manufacturing facility and to utilize new equipment at the consolidated manufacturing facility

Current openFDA PMA Record#

Device: Infinity™ Deep Brain Stimulation (DBS) IPG
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S129
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2026-03-13
Decision code: OK30
Date received: 2026-02-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to consolidate manufacturing activities from two manufacturing facilities into a single manufacturing facility and to utilize new equipment at the consolidated manufacturing facility