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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 NameREALITY FEMALE CONDOM
Classification Namecondom, female, single-use
Regulation Number884.5330
ApplicantWPC BRANDS, INC.
PMA NumberP910064
Supplement NumberS007
Date Received10/04/1993
Decision Date07/31/1995
Product Code
MBU[ Registered Establishments with MBU ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for change to the professional monograph & patient device labeling to include information on, or instructions for, the concomitant use of a spermicide containing nonoxynol-9 w/reality female condom.
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