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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFC2 FEMALE CONDOM
Classification Namecondom, female, single-use
Regulation Number884.5330
ApplicantTHE FEMALE HEALTH CO.
PMA NumberP080002
Supplement NumberS001
Date Received05/27/2011
Decision Date09/23/2011
Product Code
MBU[ Registered Establishments with MBU ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change the shelf life of the fc2 female condom from three years to four years.
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