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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
ApplicantTMJ CONCEPTS
2233 KNOLL DRIVE
VENTURA, CA 93003
PMA NumberP980052
Supplement NumberS001
Date Received01/28/2002
Decision Date03/01/2002
Product Code LZD 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT TMJ CONCEPTS, VENTURA, CALIFORNIA.
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