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U.S. Department of Health and Human Services

Product Classification
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Device polymeric neurovascular embolization
Definition Treatment of intracranial aneurysms
Physical State Polymer
Technical Method Neurointerventional
Target Area Neurovasculature
Review Panel Neurology
Product CodeOUU
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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