PMA
P940033: FEMIDOM
FDA PMA · Single-use internal condom · The Female Health Co.
Key facts
| PMA number | P940033 |
|---|---|
| Trade name | FEMIDOM |
| Generic name | Single-use internal condom |
| Applicant | The Female Health Co. |
| Owner/operator | Clear Future, Inc. |
| Product code | MBU |
| Approval date | Apr 14, 1995 |
| Docket number | 95M-0119 |
| Notice date | Jun 8, 1995 |
| Establishment registration | 3006633362 |
At a glance
- None Supplements
- Apr 14, 1995 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness 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 PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: