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U.S. Department of Health and Human Services

Product Classification

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Device catheter, neuro-vasculature, occluding ballon
Regulation Description Intravascular occluding catheter.
Definition Call for pmas - 12/26/96 per 61 fr 50708 on 9/27/96 - for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeNUF
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
Submission Type PMA
Regulation Number 882.5150
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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