HDE supplement
H980007 S002: SHELHIGH NO-REACT PORCINE PULMONIC VALVE CONDUIT
FDA HDE supplement · normal 75 day track · SHELHIGH, INC.
Key facts
| Original HDE | H980007 |
|---|---|
| Supplement number | S002 |
| Supplement type | normal 75 day track |
| Reason for the supplement | change design/components/specifications/material |
| Trade name | SHELHIGH NO-REACT PORCINE PULMONIC VALVE CONDUIT |
| Generic name | Replacement heart-valve |
| Applicant | SHELHIGH, INC. |
| Product code | DYE |
| Received date | Dec 9, 2002 |
| Decision date | Nov 24, 2003 |
| Docket number | 99M-4810 |
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: