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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 NumberS010
Date Received10/17/1997
Decision Date11/13/1997
Reclassified Date10/14/1999
Product Code LOD 
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 the elimination of a series of duplicative tests that are performed on the Surgical Simplex(R) P Bone Cement.
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