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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namecap, cervical, contraceptive
Generic Namecervical cap-barrier contraceptive device
ApplicantFEMCAP, INC.
PMA NumberP020041
Date Received09/30/2002
Decision Date03/28/2003
Product Code
LLQ[ Registered Establishments with LLQ ]
Docket Number 03M-0488
Notice Date 10/28/2003
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the femcap barrier contraceptive. The femcap is indicated for use by women of childbearing age who desire to prevent or postpone pregnancy.
Approval Order Approval Order
Supplements: S001 S002 S003