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U.S. Department of Health and Human Services

Product Classification

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Device intracranial coil-assist stent
Definition An intracranial coil-assist stent is a tubular device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck intracranial aneurysms.
Physical State The device is a tubular mesh permanent implant that is attached to a delivery wire.
Technical Method The device provides mechanical support for embolic coils that are placed into the aneurysm for treatment. The device prevents coils from prolapsing into the vessel lumen. The device is implanted using minimally invasive endovascular techniques.
Target Area Neurovasculature
Review Panel Neurology
Product CodeQCA
Premarket Review Neurological and Physical Medicine Devices (OHT5)
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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