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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 ARTICULATION SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantMicroport Orthopedics, Inc.
5677 Airline Rd.
Arlington, TN 38002
PMA NumberP030027
Supplement NumberS001
Date Received01/30/2006
Decision Date02/16/2006
Withdrawal Date07/06/2026
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  
MANUFACTURING PROCESS CHANGES BY CERAMTEC, INC., FOR THE BIOLOX FORTE CERAMIC FEMORAL HEADS AND INSERTS
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