REALITY FEMALE CONDOM
FDA premarket approval P910064/S001 · decided 1995-07-24
Approval details
- PMA number
- P910064
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- REALITY FEMALE CONDOM
- Generic name
- Single-use internal condom
- Applicant
- The Female Health Co.
- Date received
- 1993-05-26
- Decision date
- 1995-07-24
- Days to decision
- 789 days
- Decision code
- APPR
- Product code
- MBU
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Chicago, IL
- Statement
- APPROVAL FOR THE ACCELERATED & REAL-TIME AGING STUDIES TO ESTABLISH A NEW SHELF LIFE FOR THE REALITY FEMALE CONDOM
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