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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameAML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS
Classification Nameprosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Generic Nameacetabular cup hip prosthesis
Regulation Number888.3358
ApplicantDEPUY, INC.
PMA NumberP880025
Supplement NumberS003
Date Received07/08/1991
Decision Date12/04/1991
Product Code
LPH[ Registered Establishments with LPH ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
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