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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNOVATION CERAMIC AHS
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantEXACTECH, INC.
PMA NumberP050039
Supplement NumberS001
Date Received10/31/2007
Decision Date11/13/2008
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional machining processes at exactech, inc. In gainesville, florida.
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