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U.S. Department of Health and Human Services

Product Classification
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Device neurovascular liquid embolic agent
Definition Arterial occlusion of the middle meningeal artery for treatment of symptomatic subdural hematoma.
Physical State Fluid
Technical Method The agent is delivered to the middle meningeal artery where it remains in place to occlude the artery and prevent further blood flow through the artery.
Target Area Middle meningeal artery
Review Panel Neurology
Product CodeSGU
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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