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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.
 
DeviceCERAMIC TRANSCEND HIP ARTICULATION
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantMicroport Orthopedics, Inc.
5677 Airline Rd.
Arlington, TN 38002
PMA NumberP030027
Supplement NumberS009
Date Received03/11/2016
Decision Date09/01/2016
Withdrawal Date07/06/2026
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 Sterigenics US LLC, 1700 College Blvd, West Memphis, Arizona, 72301.
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