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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 NumberS006
Date Received01/27/2012
Decision Date03/15/2012
Product Code LZD 
Advisory Committee Dental
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE CLEANING DETERGENT, A CHANGE IN THE MACHINING OIL AND A MANUFACTURING PROGRAM CHANGE.
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