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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.
 
DeviceSURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantHowmedica Corp.
359 Veterans Blvd.
Rutherford, NJ 07070
PMA NumberN17004
Supplement NumberS009
Date Received06/16/1997
Decision Date08/08/1997
Reclassified Date10/14/1999
Product Code LOD 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ALTERNATIVE SUPPLIER OF METHYL METHACRYLATE MONOMER.
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