PMA P150031S040

Device: Vercise PC, Vercise Gevia and Vercise Genus DBS Systems
Applicant: Boston Scientific Corp
Product code: PJS
Decision date: 2021-10-20
Generic name: Stimulator, electrical, implanted, for essential tremor
Approval order statement: Approval to expand the current IFU to include: "Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM). The device is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability."

Current openFDA PMA Record#

Device: Vercise PC, Vercise Gevia and Vercise Genus DBS Systems
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S040
Product code: PJS
Generic name: Stimulator, electrical, implanted, for essential tremor
Decision date: 2021-10-20
Decision code: APPR
Date received: 2021-03-02
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to expand the current IFU to include: "Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM). The device is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability."