HDE supplement
H020007 S301: Activa® Dystonia Therapy System, Percept™ PC BrainSense™
FDA HDE supplement · normal 75 day track · MEDTRONIC NEUROMODULATION
Key facts
| Original HDE | H020007 |
|---|---|
| Supplement number | S301 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | Activa® Dystonia Therapy System, Percept™ PC BrainSense™ |
| Generic name | Implanted subcortical electrical stimulator (motor disorders) |
| Applicant | MEDTRONIC NEUROMODULATION |
| Product code | MRU |
| Received date | Sep 7, 2021 |
| Decision date | Feb 18, 2022 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: