PMA P140009

Device: Infinity™ Deep Brain Stimulation (DBS) IPG; Liberta RC™ DBS IPG
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S080
Product code: MHY
Decision date: 2026-04-30
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: approval to qualify an alternate second-tier supplier to provide drop-in replacements of the battery fill plug subcomponent on behalf of an Abbott’s first tier supplier

Current openFDA PMA Record#

Device: Infinity™ Deep Brain Stimulation (DBS) IPG; Liberta RC™ DBS IPG
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S131
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2026-04-30
Decision code: OK30
Date received: 2026-03-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to qualify an alternate second-tier supplier to provide drop-in replacements of the battery fill plug subcomponent on behalf of an Abbott’s first tier supplier