PMA P150031S097

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S097
Product code: NHL
Decision date: 2026-08-10
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: to update the laser excise process settings used in spinal cord stimulation and deep brain stimulation implantable pulse generators at the Clonmel facility

Current openFDA PMA Record#

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S097
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2026-08-10
Decision code: OK30
Date received: 2026-07-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to update the laser excise process settings used in spinal cord stimulation and deep brain stimulation implantable pulse generators at the Clonmel facility