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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.
 
DeviceCraniSeal Dural Sealant
Generic NameSealant, dural
ApplicantPramand, LLC
201 Burlington Rd.
Suite 210
Bedford, MA 01730
PMA NumberP220014
Supplement NumberS012
Date Received05/07/2026
Decision Date08/05/2026
Product Code NQR 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a modification to the shelf-life protocol to incorporate use of accelerated aged samples followed by confirmation with real-time aged samples.
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