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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 NumberS005
Date Received05/18/2010
Decision Date11/08/2010
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 STUDY FOR THE WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM.
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