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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceS-ROM POLY-DAIL CONSTRAINED LINER
Generic NameProsthesis, hip, constrained, cemented or uncemented, metal/polymer
Regulation Number888.3310
ApplicantDepuy, A Johnson & Johnson Co.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw, IN 46581
PMA NumberP960054
Supplement NumberS003
Date Received08/10/1999
Decision Date12/22/1999
Reclassified Date05/30/2002
Product Code KWZ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approva for the cleaning and packaging site located at DePuy (Ireland) Ltd., Loughbeg, Ringaskiddy, Cork. Ireland and the sterilization facility located at ISOTRON plc, Marcus Close, Tilehurst, Reading, Berkshire FG30 4EA, England.
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