PMA P150031S042

Device: Vercise Genus Deep Brain Stimulation (DBS) System
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S042
Product code: NHL
Decision date: 2021-05-13
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
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: Vercise Genus Deep Brain Stimulation (DBS) System
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S042
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
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.