FC2 FEMALE CONDOM
FDA premarket approval P080002 · decided 2009-03-10
Approval details
- PMA number
- P080002
- Trade name
- FC2 FEMALE CONDOM
- Generic name
- Single-use internal condom
- Applicant
- Clear Future, Inc.
- Date received
- 2008-01-08
- Decision date
- 2009-03-10
- Days to decision
- 427 days
- Decision code
- APRL
- Product code
- MBU
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- New York City, NY
- Statement
- APPROVAL FOR THE FC2 FEMALE CONDOM. THE DEVICE IS INDICATED FOR PREVENTING PREGNANCY, HIV/AIDS, AND OTHER SEXUALLY TRANSMITTED INFECTIONS (STIS).
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