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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
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NDNB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible