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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.
 
DeviceDEPUY 1 BONE CEMENT
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantDEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW, IN 46581-0988
PMA NumberP960001
Date Received01/11/1996
Decision Date02/11/1997
Reclassified Date 10/14/1999
Product Code LOD 
Docket Number 97M-0255
Notice Date 07/02/1997
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE DEPUY 1 BONE CEMENT. THIS DEVICE IS INDICATED FOR THE FIXATION OF PROSTHESES TO LIVING BONE IN ORTHOPEDIC MUSCULOSKELETAL SURGICAL PROCEDURES FOR THEUMATOID ARTHRITIS, OSTEOARTHRITIS, TRAUMATIC ARTHRITIS, OSTEOPOROSIS, AVASCULAR NECROSIS, COLLAGEN DISEASE, SEVERE JOINT DESTRUCTION SECONDARY TO TRAUMA OR OTHER CONDITIONS AND REVISION OF PREVIOUS ARTHOROPLASTY.
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
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