PMA P030017S355

Device: Precision Spinal Cord Stimulator (SCS) Systems
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S355
Product code: LGW
Decision date: 2022-12-17
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Introduce an optional weld cycle (reweld) to the Weld Case and Feedthru Laser Weld Implantable Pulse Generators process step at your Clonmel Ireland manufacturing facility.

Current openFDA PMA Record#

Device: Precision Spinal Cord Stimulator (SCS) Systems
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S355
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-12-17
Decision code: OK30
Date received: 2022-12-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Introduce an optional weld cycle (reweld) to the Weld Case and Feedthru Laser Weld Implantable Pulse Generators process step at your Clonmel Ireland manufacturing facility.