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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFC2 FEMALE CONDOM
Generic NameSingle-use internal condom
Regulation Number884.5340
ApplicantClear Future, Inc.
54 W 21st St.
Suite 610
New York City, NY 10010
PMA NumberP080002
Supplement NumberS001
Date Received03/11/2011
Decision Date09/23/2011
Reclassified Date10/29/2018
Product Code MBU 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO CHANGE THE SHELF LIFE OF THE FC2 FEMALE CONDOM FROM THREE YEARS TO FOUR YEARS.
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