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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.
 
DeviceENDURANCE BONE CEMENT
Classification Namebone cement
Generic Namebone cement
Regulation Number888.3027
Applicant
DEPUY, INC.
700 orthopaedic dr.
warsaw, IN 46581-0988
PMA NumberP960001
Supplement NumberS002
Date Received03/21/1997
Decision Date04/03/1997
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR PACKAGING DEPUY 1 BONE CEMENT POWDER WITHOUT THE FOIL POUCH
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