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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.
 
DeviceCORMET HIP RESURFACING SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/metal, resurfacing
ApplicantCorin USA
480 Paramount Dr.
Raynham, MA 02767
PMA NumberP050016
Supplement NumberS009
Date Received02/14/2012
Decision Date03/22/2013
Product Code NXT 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE REPROCESSING OF UNUSED CORMET RESURFACING HEADS THAT ARE APPROACHING THEIR EXPIRATION DATE. THE UNUSED CORMET RESURFACING HEADS WILL BE OPENED FROM THE PACKAGING, CLEANED, REPACKED, RE-STERILIZED AND RELABELED WITH A 5 YEAR SHELF LIFE.
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