HDE supplement
H050003 S242: Reclaim DBS Therapy for Obsessive Compulsive Disorder (OCD) System
FDA HDE supplement · special (immediate track) · MEDTRONIC INC.,NEUROLOGICAL DIVISION
Key facts
| Original HDE | H050003 |
|---|---|
| Supplement number | S242 |
| Supplement type | special (immediate 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 | Deep brain stimulator for obsessive compulsive disorder (ocd) |
| Applicant | MEDTRONIC INC.,NEUROLOGICAL DIVISION |
| Product code | OLM |
| Received date | Aug 4, 2020 |
| Decision date | Aug 12, 2020 |
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: