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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 U.S.A.
12750 Citrus Park Lane
Suite 120
Tampa, FL 33607
PMA NumberP050016
Supplement NumberS011
Date Received07/06/2016
Decision Date12/21/2016
Product Code NXT 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an update to the device labeling (i.e., package insert, surgical technique, and patient labeling) to include a summary of the results of the completed post-approval study (PAS).
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