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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NamePROSTHESIS, HIP, HEMI-FEMORAL, METAL
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic
ApplicantDEPUY, INC.
PMA NumberP820024
Supplement NumberS015
Date Received12/12/1990
Decision Date04/02/1991
Product Code
LPF
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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