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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 NW 66th Ct.
Gainesville, FL 32653
PMA NumberP050039
Supplement NumberS003
Date Received08/19/2009
Decision Date09/30/2009
Withdrawal Date12/31/2020
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 FROM PERFORMING FLUORESCENT PENETRANT INSPECTION (FPI) AT QC LABS TO PERFORMING THE INSPECTION STEP IN-HOUSE AS WELL AS A PROCESS CHANGE AT CERAMTEC.
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