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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 NumberS002
Date Received09/11/2006
Decision Date10/13/2006
Product Code LZD 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ARTHROTEK, INC.?S ONTARIO CALIFORNIA, FACILITY FOR THE PURCHASE OF RAW MATERIAL FOR THE MANDIBULAR BLANKS; THE CUTTING OF THIS RAW MATERIAL; AND THE ADDITION OF ANOTHER WIRE ELECTRICAL DISCHARGE MACHINE.
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