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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceF C FEMALE CONDOM
Classification Namecondom, female, single-use
Generic Namecondom, female, single-use
Applicant
THE FEMALE HEALTH CO.
515 north state st.
suite 2225
chicago, IL 60654
PMA NumberP910064
Date Received10/29/1991
Decision Date05/07/1993
Withdrawal Date 09/01/2010
Product Code
MBU[ Registered Establishments with MBU ]
Docket Number 93M-0186
Notice Date 09/01/1993
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 
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