HDE supplement
H990007 S001: CRYOLIFE INC. BIOGLUE SURGICAL ADHESIVE
FDA HDE supplement · normal 75 day track · CRYOLIFE, INC.
Key facts
| Original HDE | H990007 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | change design/components/specifications/material |
| Trade name | CRYOLIFE INC. BIOGLUE SURGICAL ADHESIVE |
| Generic name | Glue, surgical, arteries |
| Applicant | CRYOLIFE, INC. |
| Product code | MUQ |
| Received date | Jan 10, 2001 |
| Decision date | Mar 29, 2001 |
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: