HDE
H100002: CPAX ANEURYSM TREATMENT SYSTEM
FDA Humanitarian Device Exemption · NEUROVASX
Key facts
| HDE number | H100002 |
|---|---|
| Trade name | CPAX ANEURYSM TREATMENT SYSTEM |
| Generic name | Polymeric neurovascular embolization |
| Applicant | NEUROVASX |
| Product code | OUU |
| Approval date | Apr 1, 2011 |
| Docket number | 11M0241 |
At a glance
- None Supplements
- Apr 1, 2011 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: