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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.
 
DeviceC2A-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 NumberS002
Date Received05/19/2006
Decision Date06/16/2006
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  
REPLACEMENT OF THE PREVIOUS SOFTWARE SYSTEM WITH AN IMAGE ANALYZER SOFTWARE AND THE REVISION OF THE POROUS COATING TEST PROCEDURES.
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