HDE supplement
H990014 S125: ENTERRA II GASTRIC ELECTRICAL STIMULATION (GES) SYSTEM
FDA HDE supplement · 30-day notice · Enterra Medical, Inc.
Key facts
| Original HDE | H990014 |
|---|---|
| Supplement number | S125 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | ENTERRA II GASTRIC ELECTRICAL STIMULATION (GES) SYSTEM |
| Generic name | Intestinal stimulator |
| Applicant | Enterra Medical, Inc. |
| Product code | LNQ |
| Received date | Oct 25, 2016 |
| Decision date | Nov 23, 2016 |
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: