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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 NumberS015
Date Received08/01/2024
Decision Date08/08/2024
Product Code LZD 
Advisory Committee Dental
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
change of the current Process Challenge Device (PCD) used during the in-house 100% ethylene oxide (EO) sterilization of the Patient-Fitted TMJ Implants at the TMJ Concepts facility located in Ventura, CA
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