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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameP.C.A.(TM) TOTAL KNEE SYSTEM
Classification Nameprosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
Generic Nametotal knee system
Regulation Number888.3530
ApplicantHOWMEDICA CORP.
PMA NumberP840049
Supplement NumberS001
Date Received05/03/1989
Decision Date09/10/1991
Product Code
HRY[ Registered Establishments with HRY ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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