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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namecondom, female, single-use
Regulation Number884.5330
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001