PMA P150031S051

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S051
Product code: NHL
Decision date: 2022-11-22
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
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: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S051
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
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.