HDE
H980008: NEUROCONTROL VOCARE BLADDER SYSTEM
FDA Humanitarian Device Exemption · MDCI MEDICAL DEVICE CONSULTANTS, INC.
Key facts
| HDE number | H980008 |
|---|---|
| Trade name | NEUROCONTROL VOCARE BLADDER SYSTEM |
| Generic name | Electrical stimulation bladder system |
| Applicant | MDCI MEDICAL DEVICE CONSULTANTS, INC. |
| Product code | PAZ |
| Approval date | Feb 19, 1999 |
| Docket number | 99M-0255 |
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: