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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
Generic NameJoint, temporomandibular, implant
Regulation Number872.3940
ApplicantStryker Leibinger, GmbH & Co KG
Boetzinger Strasse 41, D-7911
Freiburg D-7911
PMA NumberP980052
Supplement NumberS017
Date Received07/28/2025
Decision Date03/06/2026
Product Code LZD 
Advisory Committee Dental
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the implementation of two (2) new sterile barrier heat sealing machines for use in the packaging process of patient-fitted TMJ implant
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