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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.
 
DeviceAdherus AutoSpray Dural Sealant, NUS-106
Generic NameSealant, dural
ApplicantStryker Leibinger GmbH & Co KG
Boetzinger Strasse 41
Freiburg D-7911
PMA NumberP130014
Supplement NumberS014
Date Received02/09/2022
Decision Date02/14/2022
Product Code NQR 
Advisory Committee Neurology
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  
Shift in the tolerance range for the Nozzle-Insert component of the Adherus AutoSpray Dural Sealant.
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