FC2 FEMALE CONDOM
FDA premarket approval P080002/S001 · decided 2011-09-23
Approval details
- PMA number
- P080002
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FC2 FEMALE CONDOM
- Generic name
- Single-use internal condom
- Applicant
- Clear Future, Inc.
- Date received
- 2011-03-11
- Decision date
- 2011-09-23
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- MBU
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- New York City, NY
- Statement
- APPROVAL TO CHANGE THE SHELF LIFE OF THE FC2 FEMALE CONDOM FROM THREE YEARS TO FOUR YEARS.
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