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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.
 
DeviceS-ROM POLY-DIAL CONSTRAINED LINER
Classification Nameprosthesis, hip, constrained, cemented or uncemented, metal/polymer
Generic Nameprosthesis, hip, constrained, cemented or uncemented, metal/polymer
Regulation Number888.3310
Applicant
DEPUY, A JOHNSON & JOHNSON CO.
p.o. box 988
700 orthopaedic drive
warsaw, IN 46581-0988
PMA NumberP960054
Date Received12/26/1996
Decision Date06/19/1997
Reclassified Date 05/30/2002
Product Code
KWZ[ Registered Establishments with KWZ ]
Docket Number 97M-0416
Notice Date 10/07/1997
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE JOHNSON AND JOHNSON'S S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER. THIS DEVICE IS INDICATED FOR USE AS A COMPONENT OF A TOTAL HIP PROSTHESIS IN PRIMARY OR REVISION PATIENTS AT HIGH RISK OF HIP DISLOCATION DUE TO A HISTORY OF PRIOR DISLOCATION, BONE LOSS, JOINT OR SOFT TISSUE LAXITY, NEUROMUSCULAR DISEASE OR INTRAOPERATIVE INSTABILITY.
Supplements: S002 S003 S004 
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