REALITY FEMALE CONDOM
FDA premarket approval P910064/S013 · decided 1997-03-07
Approval details
- PMA number
- P910064
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- REALITY FEMALE CONDOM
- Generic name
- Single-use internal condom
- Applicant
- The Female Health Co.
- Date received
- 1997-02-28
- Decision date
- 1997-03-07
- Days to decision
- 7 days
- Decision code
- APPR
- Product code
- MBU
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Chicago, IL
- Statement
- APPROVAL FOR 1)A MODIFICATION OF THE SHELF LIFE PROTOCOL TO REVISE THE FILM STRENGTH SPECIFICATION FROM 35 MPA TO 25.8 MPA; 2) A MODIFICATION ON THE SHELF LIFE PROTOCOL TO ASSESS THE FINAL RESULTS OF EACH LOT ON AN INDIVIDUAL BASIS, INSTEAD OF AS AN AVERAGE OF A SERIES; AND 3) AN EXTENSION OF THE PRODUCT SHELF LIFE FROM 36 MONTHS TO 60 MONTHS FOR PRODUCT PRODUCT MANUFACTURED AT BOTH THE WISCONSIN PHARMACAL AND THE CHARTEX MANUFACTURING PLANTS.
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