HDE supplement
H050003 S295: Percept™ PC INS with BrainSense™ (Model B35200)
FDA HDE supplement · normal 75 day track · MEDTRONIC INC.,NEUROLOGICAL DIVISION
Key facts
| Original HDE | H050003 |
|---|---|
| Supplement number | S295 |
| Supplement type | normal 75 day track |
| Reason for the supplement | change design/components/specifications/material |
| Trade name | Percept™ PC INS with BrainSense™ (Model B35200) |
| Generic name | Deep brain stimulator for obsessive compulsive disorder (ocd) |
| Applicant | MEDTRONIC INC.,NEUROLOGICAL DIVISION |
| Product code | OLM |
| Received date | Dec 22, 2022 |
| Decision date | Sep 22, 2023 |
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: