PMA P150031S064

Device: Vercise PC DBS System, Vercise Gervia DBS System, Vercise Genus DBS System
Applicant: Boston Scientific Corp
Product code: NHL
Decision date: 2024-02-29
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: Expanding the current indications for use (IFU) to include Bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability

Current openFDA PMA Record

Device: Vercise PC DBS System, Vercise Gervia DBS System, Vercise Genus DBS System
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S064
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2024-02-29
Decision code: APPR
Date received: 2023-09-29
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Expanding the current indications for use (IFU) to include Bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability