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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
Classification Nameglenoid fossa prosthesis
Regulation Number872.3950
ApplicantTMJ IMPLANTS, INC.
PMA NumberP000035
Supplement NumberS003
Date Received06/20/2002
Decision Date01/22/2004
Product Code
MPI[ Registered Establishments with MPI ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing site for the crystalclear anatomical model. The site is located at tmj implants, inc. , golden, colorado.
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