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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceFEMCAP BARRIER CONTRACEPTIVE
Generic NameCap, cervical, contraceptive
ApplicantFemcap Incorporated
23290 Schoenherr
Warren, MI 48089
PMA NumberP020041
Date Received09/30/2002
Decision Date03/28/2003
Product Code LLQ 
Docket Number 03M-0488
Notice Date 10/28/2003
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S002 S001 S003 
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