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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.
 
Trade NameTOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
Classification Namejoint, temporomandibular, implant
Regulation Number872.3940
ApplicantBIOMET MICROFIXATION
PMA NumberP020016
Supplement NumberS006
Date Received02/24/2012
Decision Date03/15/2012
Product Code
LZD[ Registered Establishments with LZD ]
Advisory Committee Dental
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the cleaning detergent, a change in the machining oil and a manufacturing program change.
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