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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePALACOS R BONE CEMENT
Classification Namebone cement
Generic Namebone cement
Regulation Number888.3027
Applicant
SMITH & NEPHEW RICHARDS, INC.
1450 brooks rd.
memphis, TN 38116
PMA NumberP810020
Date Received05/13/1981
Decision Date02/02/1984
Reclassified Date 10/14/1999
Product Code
LOD[ Registered Establishments with LOD ]
Docket Number 84M-0053
Notice Date 02/28/1984
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 
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