Medtronic DBS Therapy for Dystonia
FDA premarket approval P960009/S482 · decided 2025-11-22
Approval details
- PMA number
- P960009
- Supplement
- S482
- Supplement type
- Panel Track
- Supplement reason
- 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.
- Date received
- 2024-06-06
- Decision date
- 2025-11-22
- Days to decision
- 534 days
- Decision code
- APPR
- Product code
- SGS
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- 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 o
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |