PMA P030017S352

Device: Precision Spinal Cord Stimulator (SCS) Systems
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S352
Product code: LGW
Decision date: 2022-11-22
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Add a 6-feet device storage requirement at the Final Pack Automated Test Equipment (ATE) functional test step for Implantable Pulse Generators at the Clonmel Ireland manufacturing site.

Current openFDA PMA Record#

Device: Precision Spinal Cord Stimulator (SCS) Systems
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S352
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-11-22
Decision code: OK30
Date received: 2022-11-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add a 6-feet device storage requirement at the Final Pack Automated Test Equipment (ATE) functional test step for Implantable Pulse Generators at the Clonmel Ireland manufacturing site.