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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 NumberS006
Date Received05/01/2025
Decision Date05/29/2025
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  
a revision to the swell percent test method
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