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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 PATIAL KNEE SYSTEM
Classification Nameprosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw, IN 46581-0587
PMA NumberP010014
Supplement NumberS036
Date Received07/02/2012
Decision Date08/02/2012
Product Code
NRA[ Registered Establishments with NRA ]
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR UPDATES TO THE PACKAGE INSERT WHICH INCLUDED THE FOLLOWING: STRENGTHENING AND CLARIFICATION OF THE IMPORTANCE OF FOLLOWING THE SURGICAL TECHNIQUE, ADDITIONAL WORDING TO CLARIFY A PRECAUTION TO THE END USER, EXPANDED LANGUAGE FOR A POSSIBLE ADVERSE EVENT ABOUT FOREIGN MATERIAL SENSITIVITY AND REFORMATTING OF THE MAGNETIC RESONANCE (MR) SECTION.
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