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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
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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