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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
12750 citrus park lane
suite 120
tampa, FL 33607
PMA NumberP050016
Supplement NumberS012
Date Received01/25/2019
Decision Date07/17/2020
Product Code NXT 
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an update to the device labeling (i.e., package insert) to include a summary of the results of the completed long-term post-approval study (PAS).