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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCORMET HIP RESURFACING SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/metal, resurfacing
Generic Namemetal-on-metal hip resurfacing system
ApplicantCORIN U.S.A.
PMA NumberP050016
Supplement NumberS005
Date Received11/02/2009
Decision Date12/03/2009
Product Code
NXT[ Registered Establishments with NXT ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the package insert and patient brochure to include two additional potential adverse effects, pseudotumours and avascular lymphocyte dominated vasculitis associated lesions (alval) as well as an additional precaution that the subject device has not been tested in the magnetic resonance (mr) environment.
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