PMA
P020041: FEMCAP BARRIER CONTRACEPTIVE
FDA PMA · Cap, cervical, contraceptive · Femcap Incorporated
Key facts
| PMA number | P020041 |
|---|---|
| Trade name | FEMCAP BARRIER CONTRACEPTIVE |
| Generic name | Cap, cervical, contraceptive |
| Applicant | Femcap Incorporated |
| Owner/operator | FemCap Inc. |
| Product code | LLQ |
| Approval date | Mar 28, 2003 |
| Docket number | 03M-0488 |
| Notice date | Oct 28, 2003 |
| Establishment registration | 3002764647 |
| FEI number | 3002764647 |
At a glance
- 1–9 Supplements
- Aug 21, 2013 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- No Withdrawn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: