PMA P010032S179

Device: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S179
Product code: LGW
Decision date: 2021-07-28
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Implementation of a reduced sample size for bacterial endotoxin and bioburden testing for finished devices manufactured at Plano, TX and Arecibo, PR facility.

Current openFDA PMA Record#

Device: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S179
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2021-07-28
Decision code: OK30
Date received: 2021-07-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a reduced sample size for bacterial endotoxin and bioburden testing for finished devices manufactured at Plano, TX and Arecibo, PR facility.