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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.
 
DeviceTOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
Generic Namejoint, temporomandibular, implant
Regulation Number872.3940
ApplicantBIOMET MICROFIXATION, INC.
1520 tradeport dr.
jacksonville, FL 32218
PMA NumberP020016
Supplement NumberS003
Date Received09/24/2009
Decision Date10/21/2009
Product Code LZD 
Advisory Committee Dental
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A STAND-ALONE SURGICAL TECHNIQUE MANUAL.
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