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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.
 
DeviceDURALOC(TM) 300S ACETABULAR CUP WITH POROCOAT(TM)
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Regulation Number888.3358
ApplicantDepuy, Inc.
P.O. Box 988
Warsaw, IN 46581
PMA NumberP880025
Supplement NumberS001
Date Received08/03/1990
Decision Date02/08/1991
Product Code LPH 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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