PMA P960009S482

Device: Medtronic DBS Therapy for Dystonia
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S482
Product code: SGS
Decision date: 2025-11-22
Classification: Neurology
Generic name: Deep Brain Stimulation for the treatment of Dystonia
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

Current openFDA PMA Record#

Device: Medtronic DBS Therapy for Dystonia
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S482
Product code: SGS
Generic name: Deep Brain Stimulation for the treatment of Dystonia
Decision date: 2025-11-22
Decision code: APPR
Date received: 2024-06-06
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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