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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 NamePATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM
Classification Namejoint, temporomandibular, implant
Generic Nametotal temporomandibular joint prosthesis
Regulation Number872.3940
ApplicantTMJ CONCEPTS
PMA NumberP980052
Supplement NumberS004
Date Received03/03/2009
Decision Date09/02/2009
Product Code
LZD[ Registered Establishments with LZD ]
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modified labeling.
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