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  6. Vercise PC, Vercise Gevia, and Vercise Genus Deep Brain Stimulation Systems – P150031/S064
  1. Recently-Approved Devices

Vercise PC, Vercise Gevia, and Vercise Genus Deep Brain Stimulation Systems – P150031/S064

 

Vercise PC, Vercise Gevia, and Vercise Genus Deep Brain Stimulation Systems are an additional therapy placed in the brain

 

This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval.

Product Name: Vercise PC, Vercise Gevia, and Vercise Genus Deep Brain Stimulation (DBS) Systems
PMA Applicant: Boston Scientific Corporation
Address: 25155 Rye Canyon Loop, Valencia, CA 91355
Approval Date: February 29, 2024
Approval Letter: Approval Order

What is it?

The Vercise PC, Vercise Gevia, and Vercise Genus Deep Brain Stimulation (DBS) Systems are implantable devices that deliver low-intensity electrical pulses to nerve centers in the brain. These DBS systems consist of the following components:

  • An implantable pulse generator (IPG) (non-rechargeable or rechargeable)
  • A clinician programmer (a program on a tablet that provides a health care provider information)
  • A patient controller
  • A lead kit and extension kit

This supplement expands the Indications for Use to include an option of two-sided stimulation for people who are diagnosed with essential tremor not adequately controlled by medication and where the tremor creates a significant inability to function.

 
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