PMA P150031S091

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S091
Product code: NHL
Decision date: 2026-01-22
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: approval for an alternate sterilization facility and to transfer final packaging and distribution activities to another facility

Current openFDA PMA Record#

Device: Vercise Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S091
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2026-01-22
Decision code: OK30
Date received: 2025-12-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for an alternate sterilization facility and to transfer final packaging and distribution activities to another facility