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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 NumberS006
Date Received11/02/2009
Decision Date12/31/2009
Product Code NXT 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE METHOD OF STERILIZATION OF THE INDIVIDUALLY PACKAGED FLUTED GUIDE WIRE AND REVISIONS TO THE PACKAGE LABELING.
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