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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.
 
DeviceOXFORD PARTIAL KNEE SYSTEM
Generic NameProsthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
ApplicantBiomet Manufacturing Corp
56 E. Bell Dr.,
P.O. Box 587
Warsaw, IN 46581
PMA NumberP010014
Supplement NumberS028
Date Received11/09/2010
Decision Date01/07/2011
Product Code NRA 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE PACKAGE INSERT, INCLUDING THE ADDITION OF MR CONDITIONAL LABELING AND THE ASSOCIATED MR CONDITIONS OF USE.
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