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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.
 
DeviceEXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantEXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE, FL 32653
PMA NumberP050039
Supplement NumberS005
Date Received03/11/2011
Decision Date03/31/2011
Withdrawal Date 12/31/2020
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES WHICH ADD STRENGTHENING LANGUAGE TO THE FEMORAL STEM SURGICAL TECHNIQUE MANUALS.
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