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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 NumberS008
Date Received10/11/2011
Decision Date11/10/2011
Product Code NXT 
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  
MODIFICATION TO THE TYPE OF MANUFACTURING PROCESS FOR THE DEVICE.
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