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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 NumberS005
Date Received11/02/2009
Decision Date12/03/2009
Product Code NXT 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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