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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.
 
DeviceBIAS(R) FIBER METAL TOTAL HIP SYSTEM
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Regulation Number888.3358
ApplicantZimmer, Inc.
P.O. Box 708
Warsaw, IN 46580
PMA NumberP850061
Supplement NumberS001
Date Received02/08/1989
Decision Date03/29/1989
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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