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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.
 
DeviceFEM CAP
Generic NameCap, cervical, contraceptive
ApplicantFemcap Incorporated
23290 Schoenherr
Warren, MI 48089
PMA NumberP020041
Supplement NumberS002
Date Received07/14/2011
Decision Date10/13/2011
Product Code LLQ 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT HELIX MEDICAL, LLC. IN CARPINTERIA, CA93013
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