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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.
Classification Namebone cement
Generic Namebone cement
Regulation Number888.3027
ApplicantZIMMER, INC.
PMA NumberN17755
Supplement NumberS046
Date Received10/11/1995
Decision Date11/20/1995
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition to the labeling of the following warning statement: "do not centriguge osteobond copolymer bone cement. Although centrifugation has been shown in some cases to improve the physical strength of the cured cement by removal of entrapped air and other gases, a uniform dispersion of the radiopacifier cannot be assured. Therefore, the use of centrigugation is not advisable. ".