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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
Product CodeNUF
Regulation Number 882.5150
Device Class 3

Device Problems
Burst 2
Deflation issue 1
Break 1
Total Device Problems 4

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