|
Device | Vercise PC, Vercise Gevia and Vercise Genus DBS Systems |
Generic Name | Stimulator, electrical, implanted, for essential tremor |
Applicant | Boston Scientific Corp. 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P150031 |
Supplement Number | S040 |
Date Received | 03/02/2021 |
Decision Date | 10/20/2021 |
Product Codes |
MHY PJS |
Advisory Committee |
Neurology |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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." |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |