HDE supplement
H990011 S002: CARDIOSEAL SEPTAL OCCLUSION SYSTEM
FDA HDE supplement · normal 75 day track · NITINOL MEDICAL TECHNOLOGIES, INC.
Key facts
| Original HDE | H990011 |
|---|---|
| Supplement number | S002 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | CARDIOSEAL SEPTAL OCCLUSION SYSTEM |
| Generic name | Transcatheter septal occluder |
| Applicant | NITINOL MEDICAL TECHNOLOGIES, INC. |
| Product code | MLV |
| Received date | Apr 26, 2001 |
| Decision date | Jul 9, 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: