PMA P140009S080

Device: Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S080
Product code: MHY
Decision date: 2022-10-28
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Implement two manufacturing changes used in the production of contact assemblies in supplier Bal Seal Engineering, Inc.’s production of contact assemblies, i.e., 1) to qualify alternate welding equipment used to process the spring component of contact assemblies; and 2) to implement visual automated optical inspection for performing the 100% inspection of the spring component's inner diameter.

Current openFDA PMA Record#

Device: Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S080
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2022-10-28
Decision code: OK30
Date received: 2022-09-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement two manufacturing changes used in the production of contact assemblies in supplier Bal Seal Engineering, Inc.’s production of contact assemblies, i.e., 1) to qualify alternate welding equipment used to process the spring component of contact assemblies; and 2) to implement visual automated optical inspection for performing the 100% inspection of the spring component's inner diameter.