PMA
P010043: LEA'S SHIELD BARRIER CONTRACEPTIVE
FDA PMA · Cap, cervical, contraceptive · Yama, Inc.
Key facts
| PMA number | P010043 |
|---|---|
| Trade name | LEA'S SHIELD BARRIER CONTRACEPTIVE |
| Generic name | Cap, cervical, contraceptive |
| Applicant | Yama, Inc. |
| Product code | LLQ |
| Approval date | Mar 14, 2002 |
| Docket number | 02M-0471 |
| Notice date | Oct 30, 2002 |
| FEI number | 1000208910 |
At a glance
- 1–9 Supplements
- May 26, 2004 Latest supplement decision
- No Withdrawn
- Yes 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: