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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 NameCMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.
Classification Namebone cement
Generic Namebone cement
Regulation Number888.3027
ApplicantWRIGHT MEDICAL TECHNOLOGY, INC.
PMA NumberN18466
Supplement NumberS020
Date Received09/28/1995
Decision Date11/20/1995
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following:1)addition of a distributor label to be placed on to the bottom of the outer carton; and 2) the sterile powder package will be placed into a nonsterile protective laminated foil pouch.
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