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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMedtronic DBS Therapy for Dystonia
Generic NameDeep Brain Stimulation for the treatment of Dystonia
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS482
Date Received06/06/2024
Decision Date11/22/2025
Product Code SGS 
Docket Number 25M-6405
Notice Date 11/24/2025
Advisory Committee Neurology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for expanding the indications for use to include the following: Bilateral stimulation of the internal globus pallidus (GPi) using Medtronic DBS therapy for Dystonia is indicated as an aid in the management of chronic, intractable (oral and/or injectable medication refractory) primary dystonia, including: 1) generalized dystonia, segmental dystonia of the head and neck, and cervical dystonia (torticollis) in adult patients; and 2) generalized dystonia in pediatric patients twelve years of age or above
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
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