HDE
H970005: PERMA-FLOW CORONARY GRAFT MODEL 2C10
FDA Humanitarian Device Exemption · POSSIS MEDICAL, INC.
Key facts
| HDE number | H970005 |
|---|---|
| Trade name | PERMA-FLOW CORONARY GRAFT MODEL 2C10 |
| Generic name | Graft, bypass, coronary artery |
| Applicant | POSSIS MEDICAL, INC. |
| Product code | NAV |
| Approval date | Apr 30, 1998 |
| Docket number | 98M-0452 |
At a glance
- None Supplements
- Apr 30, 1998 Latest supplement decision
- No 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: