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U.S. Department of Health and Human Services

Product Classification
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Device sealant, dural
Definition Dural sealants are devices intended to aid in preventing cerebrospinal fluid leakage through suture-approximated dural wound edges.The sealant is sprayed or layered onto sutured dural wound edges and allowed to polymerize in place.
Review Panel Neurology
Product CodeNQR
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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