PMA P150031S100

Device: Vercise DBS Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S100
Product code: NHL
Decision date: 2026-10-15
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: approval for providing additional guidance in the use of Clinician Programmer feature for Implantable Pulse Generator (IPG) battery recharge interval and non-rechargeable IPG battery longevity estimates.

Current openFDA PMA Record#

Device: Vercise DBS Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S100
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2026-10-15
Decision code: APPR
Date received: 2026-09-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for providing additional guidance in the use of Clinician Programmer feature for Implantable Pulse Generator (IPG) battery recharge interval and non-rechargeable IPG battery longevity estimates.