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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 HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantBiomet, Inc.
P.O. Box 587
Warsaw, IN 46581-0587
PMA NumberP050009
Supplement NumberS009
Date Received02/16/2010
Decision Date02/11/2011
Withdrawal Date 07/23/2015
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO SUSPEND THE POST APPROVAL STUDY BASED ON SUSPENSION OF MARKETING AND SALES IN THE US.
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