PMA P150031S092

Device: Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S092
Product code: NHL
Decision date: 2026-05-28
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: approval for change from the Surface Pro 6 (SP6) to Surface Pro 7 (SP7) as the off-the-shelf hardware used for the Clinician Programmer software

Current openFDA PMA Record#

Device: Deep Brain Stimulation (DBS) Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S092
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2026-05-28
Decision code: APPR
Date received: 2026-03-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for change from the Surface Pro 6 (SP6) to Surface Pro 7 (SP7) as the off-the-shelf hardware used for the Clinician Programmer software