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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.
 
DeviceCERAMAX CERAMIC TOTAL HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantDePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw, IN 46582
PMA NumberP070026
Supplement NumberS031
Date Received07/24/2015
Decision Date05/04/2016
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Orchid Orthopedics Solutions, 4600 East Shelby Drive, Suite 1, Memphis, Tennessee, 38118.
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