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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 ET AutoSpray Dural Sealant, NUS-109
Generic NameSealant, dural
ApplicantStryker Leibinger GmbH & Co KG
Boetzinger Strasse 41
Freiburg D-7911
PMA NumberP130014
Supplement NumberS015
Date Received03/04/2022
Decision Date03/16/2022
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  
Steris Applied Technologies dba Synergy Health AST, LLC facility located in Saxonburg, Pennsylvania (Steris AST Saxonburg) to use a functionally equivalent electron accelerator to sterilize Adherus AutoSpray ET Dural Sealants
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