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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 NumberS010
Date Received10/17/1997
Decision Date11/13/1997
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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