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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 NameSURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
Classification Namebone cement
Generic Namebone cement
Regulation Number888.3027
ApplicantHOWMEDICA CORP.
PMA NumberN17004
Supplement NumberS008
Date Received11/18/1996
Decision Date12/18/1996
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor changes to packaging and labeling of the product.
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