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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceREALITY FEMALE CONDOM
Generic NameSingle-use internal condom
Regulation Number884.5340
ApplicantTHE FEMALE HEALTH CO.
515 NORTH STATE ST.
SUITE 2225
CHICAGO, IL 60654
PMA NumberP910064
Supplement NumberS009
Date Received01/18/1994
Decision Date07/24/1995
Withdrawal Date 09/01/2010
Product Code MBU 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITIONAL DATA PROVIDED ON THE IN VITRO BARRIER PROPERTIES OF THE DEVICE WITH RESPECT TO SEXUALLY TRANSMITTED DISEASES.THESE DATA WERE PROVIDED IN SATISFACTION OF THE CONDITIONS OF APPROVAL CONTAINED IN FDA'S MAY 7, 1993 LETTER
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