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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.
 
DeviceC2-A TAPER ACETABULAR SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantBiomet, Inc.
P.O. Box 587
Warsaw, IN 46581
PMA NumberP050009
Supplement NumberS005
Date Received11/02/2007
Decision Date11/30/2007
Withdrawal Date07/23/2015
Product Code MRA 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE BY THE SUPPLIER TO IMPLEMENT NEW SOFTWARE ON THE MANUFACTURING LINE.
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