HDE supplement
H050003 S094: RECLAIM DBS THERAPY FOR OBSESSIVE COMPULSIVE DISORDER (OCD) SYSTEM
FDA HDE supplement · normal 75 day track · MEDTRONIC INC.,NEUROLOGICAL DIVISION
Key facts
| Original HDE | H050003 |
|---|---|
| Supplement number | S094 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | RECLAIM DBS THERAPY FOR OBSESSIVE COMPULSIVE DISORDER (OCD) SYSTEM |
| Generic name | Stimulator, brain, implanted, for behavior modification |
| Applicant | MEDTRONIC INC.,NEUROLOGICAL DIVISION |
| Product code | MFR |
| Received date | Nov 17, 2014 |
| Decision date | Nov 4, 2015 |
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: