PMA supplement
P960009 S482: Medtronic DBS Therapy for Dystonia
FDA PMA supplement · Panel Track · Medtronic, Inc.
Key facts
| Original PMA | P960009 |
|---|---|
| Supplement number | S482 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Medtronic DBS Therapy for Dystonia |
| Generic name | Deep Brain Stimulation for the treatment of Dystonia |
| Applicant | Medtronic, Inc. |
| Product code | SGS |
| Received date | Jun 6, 2024 |
| Decision date | Nov 22, 2025 |
| Docket number | 25M-6405 |
| Notice date | Nov 24, 2025 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: