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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 NameEXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantEXACTECH, INC.
PMA NumberP050039
Supplement NumberS003
Date Received08/31/2009
Decision Date09/30/2009
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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