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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 NameTMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS
Classification Nameglenoid fossa prosthesis
Regulation Number872.3950
ApplicantTMJ IMPLANTS, INC.
PMA NumberP000035
Supplement NumberS004
Date Received12/26/2002
Decision Date10/14/2003
Product Code
MPI[ Registered Establishments with MPI ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the packaging/shelf life testing protocol to extend the shelf life beyond 6 months.
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