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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.
 
DeviceSpineSeal Spine Sealant
Generic NameSealant, dural
ApplicantPramand, LLC
201 Burlington Rd., Suite 210
Bedford, MA 02420
PMA NumberP240027
Supplement NumberS002
Date Received03/06/2025
Decision Date06/04/2025
Product Code NQR 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to the syringes that contain the precursor and diluent solution components.
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