PMA
P080002: FC2 FEMALE CONDOM
FDA PMA · Single-use internal condom · Clear Future, Inc.
Key facts
| PMA number | P080002 |
|---|---|
| Trade name | FC2 FEMALE CONDOM |
| Generic name | Single-use internal condom |
| Applicant | Clear Future, Inc. |
| Owner/operator | Clear Future, Inc. |
| Product code | MBU |
| Approval date | Mar 10, 2009 |
| Docket number | 09M-0159 |
| Notice date | Mar 25, 2009 |
| Establishment registration | 3006633362 |
| FEI number | 3006633362 |
At a glance
- 1–9 Supplements
- Jun 23, 2017 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: