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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 NumberS005
Date Received05/18/2010
Decision Date11/08/2010
Product Code
LZD[ Registered Establishments with LZD ]
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for proposed labeling changes following the conclusion of the postmarket study for the walter lorenz total temporomandibular joint replacement system.
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