Vercise Deep Brain Stimulation (Dbs)System

FDA premarket approval P150031 · Stimulator, electrical, implanted, for parkinsonian symptoms

PMA numberP150031

Approval

Applicant
Boston Scientific Corp
Received
August 26, 2015
Decision date
December 8, 2017 (APPR)
Supplements
92, latest September 13, 2026
Product code
NHL – Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

Official FDA PMA record

Approval order statement

Approval for the Vercise DBS System. The device is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) in the treatment of patients with moderate to advanced levodopa-responsive Parkinsons disease (PD), which is not adequately controlled with medication.