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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.
Classification Namecap, cervical, contraceptive
Generic Namecervical cap-barrier contraceptive device
ApplicantFEMCAP, INC.
PMA NumberP020041
Supplement NumberS001
Date Received09/02/2005
Decision Date02/15/2006
Product Code
LLQ[ Registered Establishments with LLQ ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a protocol to extend the shelf life of the femcap contraceptive barrier from three years to five years.