PMA P030017S345

Device: Wave Writer Alpha Spinal Cord Stimulator (SCS) System
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S345
Product code: LGW
Decision date: 2021-05-13
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Add an alternate semi-automated process for the final packaging activities for the sterile-packaged Implantable Pulse Generators at the Boston Scientific Clonmel Ireland facility.

Current openFDA PMA Record#

Device: Wave Writer Alpha Spinal Cord Stimulator (SCS) System
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S345
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2021-05-13
Decision code: OK30
Date received: 2021-05-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add an alternate semi-automated process for the final packaging activities for the sterile-packaged Implantable Pulse Generators at the Boston Scientific Clonmel Ireland facility.