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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 NumberS011
Date Received02/03/1998
Decision Date03/18/1998
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for isotron ireland, ltd. , to be certified as an alternate supplier for your eto sterilization process.
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