REALITY FEMALE CONDOM
FDA premarket approval P910064/S007 · decided 1995-07-31
Approval details
- PMA number
- P910064
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REALITY FEMALE CONDOM
- Generic name
- Single-use internal condom
- Applicant
- The Female Health Co.
- Date received
- 1993-10-04
- Decision date
- 1995-07-31
- Days to decision
- 665 days
- Decision code
- APPR
- Product code
- MBU
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Chicago, IL
- Statement
- APPROVAL FOR CHANGE TO THE PROFESSIONAL MONOGRAPH & PATIENT DEVICE LABELING TO INCLUDE INFORMATION ON, OR INSTRUCTIONS FOR, THE CONCOMITANT USE OF A SPERMICIDE CONTAINING NONOXYNOL-9 W/REALITY FEMALE CONDOM
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