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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 NumberS022
Date Received12/18/2025
Decision Date07/15/2026
Product Code NQR 
Advisory Committee Neurology
Clinical TrialsNCT04498026
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Adherus AutoSpray Dural Sealant and Adherus AutoSpray ET Dural Sealant are indicated for use in patients who are 13 years of age and older, as an adjunct to standard methods of dural repair, such as sutures, to provide watertight closure during cranial and spinal procedures.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
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