HDE supplement
H990014 S064: ENTERRA INS/UNIPOLAR MUSCULAR LEAD
FDA HDE supplement · special (immediate track) · Enterra Medical, Inc.
Key facts
| Original HDE | H990014 |
|---|---|
| Supplement number | S064 |
| Supplement type | special (immediate track) |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | ENTERRA INS/UNIPOLAR MUSCULAR LEAD |
| Generic name | Intestinal stimulator |
| Applicant | Enterra Medical, Inc. |
| Product code | LNQ |
| Received date | Jul 29, 2011 |
| Decision date | Aug 26, 2011 |
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: