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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 NumberS002
Date Received11/21/2023
Decision Date12/20/2023
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 change to improve the repeatability of a quality control test method for the CraniSeal precursors
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