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U.S. Department of Health and Human Services

Product Classification
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Device intracranial aneurysm flow diverter
Definition Treatment of wide-necked and larger or giant intracranial aneurysms.
Physical State metallic
Technical Method interventional
Target Area neurovasculature
Review Panel Neurology
Product CodeOUT
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? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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