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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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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