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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 NameS-ROM POLY-DIAL CONSTRAINED LINER
Classification Nameprosthesis, hip, constrained, cemented or uncemented, metal/polymer
Regulation Number888.3310
ApplicantDEPUY, A JOHNSON & JOHNSON CO.
PMA NumberP960054
Supplement NumberS004
Date Received10/06/1999
Decision Date11/10/1999
Product Code
KWZ[ Registered Establishments with KWZ ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason location change: packager
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a cleaning and packaging facility located at depuy orthopaedics, inc. , 700 orthopaedic drive, warsaw, in 46581.
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