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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 (TMJ) REPLACEMENT SYSTEM
Generic Namejoint, temporomandibular, implant
Regulation Number872.3940
ApplicantBIOMET MICROFIXATION, INC.
1520 tradeport dr.
jacksonville, FL 32218
PMA NumberP020016
Supplement NumberS008
Date Received12/14/2016
Decision Date06/08/2017
Product Code LZD 
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR PROPOSED LABELING CHANGES FOLLOWING THE CONCLUSION OF THE POSTMARKET SURVEILLANCE STUDY FOR THE TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM.
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