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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, Adherus AutoSpray ET Dural Sealant
Generic NameSealant, dural
ApplicantStryker Leibinger GmbH & Co KG
Boetzinger Strasse 41
Freiburg D-7911
PMA NumberP130014
Supplement NumberS006
Date Received08/16/2019
Decision Date09/18/2019
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  
Add an alternate supplier for the bacterial endotoxin test assay.
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