PMA P010032S188

Device: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S188
Product code: LGW
Decision date: 2022-06-28
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Implement the previously approved, feed-thru design at the Abbott PR manufacturing facility with their separate welding process.

Current openFDA PMA Record#

Device: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S188
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-06-28
Decision code: OK30
Date received: 2022-06-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement the previously approved, feed-thru design at the Abbott PR manufacturing facility with their separate welding process.