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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 and ET Dural Sealant
Generic NameSealant, dural
ApplicantStryker Leibinger GmbH & Co KG
Boetzinger Strasse 41
Freiburg D-7911
PMA NumberP130014
Supplement NumberS005
Date Received02/12/2018
Decision Date07/31/2018
Product Code NQR 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for manufacturing sites located at STERIS Applied Sterilization Technologies (AST) dba Synergy Health AST, LLC, 7225 North Noah Drive, Saxonburg, Pennsylvania 16056 and STERIS Applied Sterilization Technologies (AST) dba Synergy Health AST, LLC, 3200 Lakeville Hwy, Suite 120, Petaluma, California 94954, as contract sterilizers.
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