PMA supplement
P960009 S478: Activa®, Percept™ and SenSight™ Deep Brain Stimulation Therapy System
FDA PMA supplement · Panel Track · Medtronic, Inc.
Key facts
| Original PMA | P960009 |
|---|---|
| Supplement number | S478 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Activa®, Percept™ and SenSight™ Deep Brain Stimulation Therapy System |
| Generic name | Stimulator, electrical, implanted, for parkinsonian symptoms |
| Applicant | Medtronic, Inc. |
| Product code | NHL |
| Received date | Apr 17, 2024 |
| Decision date | Feb 20, 2025 |
| Docket number | 25M-0480 |
| Notice date | Mar 3, 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: