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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.
 
DeviceTMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM
Generic Namejoint, temporomandibular, implant
Regulation Number872.3940
Applicant
TMJ CONCEPTS
2233 knoll drive
ventura, CA 93003
PMA NumberP980052
Supplement NumberS002
Date Received11/27/2002
Decision Date01/14/2003
Product Code LZD 
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF THE STERILE PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TO BE STERILIZED AT TMJ CONCEPTS, VENTURA, CALIFORNIA.
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