PMA P140009S125

Device: DBS Neurostimulation System
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S125
Product code: MHY
Decision date: 2025-09-25
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: the following changes for the shaft of the torque wrench accessory of the approved SCS, DBS, and DRG Neurostimulation systems: 1) Second-tier supplier manufacturing process relocation2) Validation of new, equivalent equipment at new site

Current openFDA PMA Record#

Device: DBS Neurostimulation System
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S125
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2025-09-25
Decision code: OK30
Date received: 2025-08-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the following changes for the shaft of the torque wrench accessory of the approved SCS, DBS, and DRG Neurostimulation systems: 1) Second-tier supplier manufacturing process relocation2) Validation of new, equivalent equipment at new site