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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 NameFEM CAP
Classification Namecap, cervical, contraceptive
Generic Namecervical cap-barrier contraceptive device
ApplicantFEMCAP, INC.
PMA NumberP020041
Supplement NumberS002
Date Received07/14/2011
Decision Date10/13/2011
Product Code
LLQ[ Registered Establishments with LLQ ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: packager
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at helix medical, llc. In carpinteria, ca 93013.