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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.
 
DeviceZIMMER(R) BONE CEMENT DOUGH-TYPE, ZIMMER(R) L.V.C.(R) LOW VIXCOSITY BONE CEMENT AND OSTEOBOND(TM) COPOLYMER BONE CEMENT
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantZimmer, Inc.
P.O. Box 708
Warsaw, IN 46581
PMA NumberN17755
Supplement NumberS045
Date Received06/22/1995
Decision Date10/17/1996
Reclassified Date10/14/1999
Product Code LOD 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN ETHYLENE OXIDE STERILIZATIN PROCESS USED IN THE STERILIZATION OF THE EXTERNAL SURFACE OF THE BONE CEMENT'S MONOMER AMPULES
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