PMA P140009S079

Device: Deep Brain Stimulation (DBS) System
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S079
Product code: MHY
Decision date: 2022-10-17
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Qualify an additional manufacturing site in Bethel, Connecticut to manufacture nitinol tubes, which will be used in the manufacture of the DBS Extensions.

Current openFDA PMA Record#

Device: Deep Brain Stimulation (DBS) System
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S079
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2022-10-17
Decision code: OK30
Date received: 2022-09-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualify an additional manufacturing site in Bethel, Connecticut to manufacture nitinol tubes, which will be used in the manufacture of the DBS Extensions.