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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.
DevicePatient-Fitted TMJ Reconstruction Prosthesis System
Generic Namejoint, temporomandibular, implant
Regulation Number872.3940
2233 knoll drive
ventura, CA 93003
PMA NumberP980052
Supplement NumberS008
Date Received10/27/2020
Decision Date11/24/2020
Product Code LZD 
Advisory Committee Dental
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Change to implement new sterilization equipment for the same approved sterilization type and cycle.