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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device surgical kit
Definition For creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.
Product CodePAX
Device Class Humanitarian Device Exemption

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