HDE supplement
H990014 S169: Enterra II Therapy System
FDA HDE supplement · normal 75 day track · Enterra Medical, Inc.
Key facts
| Original HDE | H990014 |
|---|---|
| Supplement number | S169 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | Enterra II Therapy System |
| Generic name | Intestinal stimulator |
| Applicant | Enterra Medical, Inc. |
| Product code | LNQ |
| Received date | Apr 8, 2019 |
| Decision date | Aug 22, 2019 |
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: