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U.S. Department of Health and Human Services

Product Classification
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Device intrasaccular flow disruption device
Definition An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach.
Physical State A metal mesh-like implant attached to a delivery system.
Technical Method An intrasaccular flow disruption device is a prescription use only device used to treat wide-neck intracranial aneurysms. The device is delivered into the neurovasculature with an endovascular approach, implanted within the sac of the intracranial aneurysm, and covers the neck of the intracranial aneurysm to obstruct blood from entering the intracranial aneurysm sac.
Target Area Neurovasculature, intracranial aneurysms.
Review Panel Neurology
Product CodeOPR
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
Third Party Review Not Third Party Eligible
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