HDE supplement
H050003 S081: ACTIVA/ KINETRA/ SOLETRA DEEP BRAIN STIMULATION SYSTEMS
FDA HDE supplement · 30-day notice · MEDTRONIC INC.,NEUROLOGICAL DIVISION
Key facts
| Original HDE | H050003 |
|---|---|
| Supplement number | S081 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | ACTIVA/ KINETRA/ SOLETRA DEEP BRAIN STIMULATION SYSTEMS |
| Generic name | Stimulator, brain, implanted, for behavior modification |
| Applicant | MEDTRONIC INC.,NEUROLOGICAL DIVISION |
| Product code | MFR |
| Received date | Apr 25, 2014 |
| Decision date | May 23, 2014 |
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: