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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.
 
DeviceDEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantDEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46582
PMA NumberP070026
Supplement NumberS004
Date Received11/01/2011
Decision Date04/02/2013
Product Code MRA 
Docket Number 13M-0462
Notice Date 04/24/2013
Advisory Committee Orthopedic
Clinical TrialsNCT00953719
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM. THIS DEVICE IS INDICATED FOR NONCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS UNDERGOING PRIMARY TOTAL HIP REPLACEMENT SURGERY FOR REHABILITATIONOF HIPS DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR ANY OF ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS, AVASCULAR NECROSIS, AND POST-TRAUMATIC ARTHRITIS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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