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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
Classification Namejoint, temporomandibular, implant
Regulation Number872.3940
ApplicantWALTER LORENZ SURGICAL, INC.
PMA NumberP020016
Supplement NumberS001
Date Received04/28/2006
Decision Date05/26/2006
Product Code
LZD[ Registered Establishments with LZD ]
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at walter lorenz surgical, inc. S jacksonville, florida facility for the wire electrical discharge machining manufacturing process.
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