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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
Generic NameSealant, dural
ApplicantStryker Leibinger GmbH & Co KG
Boetzinger Strasse 41
Freiburg D-7911
PMA NumberP130014
Supplement NumberS002
Date Received02/02/2016
Decision Date08/02/2016
Product Code NQR 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes in a nozzle design and packaging of the Adherus Autospray ET (Extended Tip) Dural Sealant.
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