HDE
H980007: SHELHIGH NO-REACT PORCINE PULMONIC VALVE CONDUIT
FDA Humanitarian Device Exemption · SHELHIGH, INC.
Key facts
| HDE number | H980007 |
|---|---|
| Trade name | SHELHIGH NO-REACT PORCINE PULMONIC VALVE CONDUIT |
| Generic name | Pulmonic replacement heart valve |
| Applicant | SHELHIGH, INC. |
| Product code | PAL |
| Approval date | Sep 30, 1999 |
| Docket number | 99M-4810 |
At a glance
- 1–9 Supplements
- Nov 24, 2003 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: