HDE supplement
H020007 S054: SOLETRA/LEADS/EXTENSIONS/ACTIVA THERAPY DYSTONIA KIT
FDA HDE supplement · special (immediate track) · MEDTRONIC NEUROMODULATION
Key facts
| Original HDE | H020007 |
|---|---|
| Supplement number | S054 |
| Supplement type | special (immediate track) |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | SOLETRA/LEADS/EXTENSIONS/ACTIVA THERAPY DYSTONIA KIT |
| Generic name | Implanted subcortical electrical stimulator (motor disorders) |
| Applicant | MEDTRONIC NEUROMODULATION |
| Product code | MRU |
| Received date | Jul 29, 2011 |
| Decision date | Aug 26, 2011 |
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: