Product Classification

• Device: polymeric neurovascular embolization
• Definition: Treatment of intracranial aneurysms.
• Physical State: Polymer
• Technical Method: Neurointerventional
• Target Area: Neurovasculature
• Review Panel: Neurology
• Product Code: OUU
• Submission Type: HDE
• Device Class: 3 (De Novo Petitions Granted)
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

Not Third Party Eligible