HDE
H970003: URO-STIM THERAPEUTIC STIMULATION UNIT
FDA Humanitarian Device Exemption · WILLIAM E. KAPLAN, M.D.
Key facts
| HDE number | H970003 |
|---|---|
| Trade name | URO-STIM THERAPEUTIC STIMULATION UNIT |
| Generic name | Stimulator, bladder |
| Applicant | WILLIAM E. KAPLAN, M.D. |
| Product code | NAZ |
| Approval date | Dec 16, 1997 |
| Docket number | 98M-0163 |
At a glance
- 1–9 Supplements
- Apr 8, 1999 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: