HDE supplement
H030005 S001: COAXIA NEUROFLO CATHETER
FDA HDE supplement · normal 75 day track · ZOLL CIRCULATION
Key facts
| Original HDE | H030005 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | COAXIA NEUROFLO CATHETER |
| Generic name | Catheter, neurovasculature, occluding balloon |
| Applicant | ZOLL CIRCULATION |
| Product code | NUF |
| Received date | Mar 30, 2006 |
| Decision date | Sep 8, 2006 |
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: