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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.
 
DeviceFC2 FEMALE CONDOM
Classification Namecondom, female, single-use
Generic Namecondom, female, single-use
Applicant
Veru, Inc.
4400 biscayne blvd
suite #888
miami, FL 33137
PMA NumberP080002
Date Received01/08/2008
Decision Date03/10/2009
Product Code
MBU[ Registered Establishments with MBU ]
Docket Number 09M-0159
Notice Date 03/25/2009
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE FC2 FEMALE CONDOM. THE DEVICE IS INDICATED FOR PREVENTING PREGNANCY, HIV/AIDS, AND OTHER SEXUALLY TRANSMITTED INFECTIONS (STIS).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 
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