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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.
 
DeviceFEMCAP CONTRACEPTIVE BARRIER DEVICE
Generic NameCap, cervical, contraceptive
ApplicantFemcap Incorporated
23290 Schoenherr
Warren, MI 48089
PMA NumberP020041
Supplement NumberS001
Date Received09/02/2005
Decision Date02/15/2006
Product Code LLQ 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A PROTOCOL TO EXTEND THE SHELF LIFE OF THE FEMCAP CONTRACEPTIVE BARRIER FROM THREE YEARS TO FIVE YEARS.
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