PMA P140009

Device: Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S080
Product code: MHY
Decision date: 2026-07-17
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: approval for the shelf-life extension changes of the raw materials used in the manufacture of the SCS and DBS leads, extensions and adapters

Current openFDA PMA Record#

Device: Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S134
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2026-07-17
Decision code: OK30
Date received: 2026-06-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the shelf-life extension changes of the raw materials used in the manufacture of the SCS and DBS leads, extensions and adapters