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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceOXFORD MENISCAL UNICOMPARTMENTAL 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 NumberS011
Date Received11/15/2006
Decision Date12/15/2006
Product Code
NRA[ Registered Establishments with NRA ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the minimum and maximum parameters for the dwell time during the heat sealing f blister packs.
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