PMA P010032S194

Device: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S194
Product code: LGW
Decision date: 2022-10-28
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
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: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S194
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
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.