HDE
H980005: NEUROCONTROL CORPORATION VOCARE BLADDER SYSTEM
FDA Humanitarian Device Exemption · MDCI
Key facts
| HDE number | H980005 |
|---|---|
| Trade name | NEUROCONTROL CORPORATION VOCARE BLADDER SYSTEM |
| Generic name | Bladder system |
| Applicant | MDCI |
| Product code | PAT |
| Approval date | Dec 28, 1998 |
| Docket number | 99M-0150 |
At a glance
- 1–9 Supplements
- Oct 31, 2005 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: