Definition: The Neurovascular Embolization Device Is Placed In A Blood Vessel To Permanenty Obstruct Blood Flow To An Intracranial Aneurysm Or Other Vascular Malformation. The Device Polymerizes Or Precipitates In Situ.
| Device Type ID | 3855 |
| Device Name | Polymerizing, Neurovascular Embolization Material |
| Physical State | The Embolization Agent Is Dissolved In DMSO (dimethyl Sulfoxide, An Organic Solvent); Ethylene Vinyl Alcohol Co-polymer (EVOH, The Embolization Agent) Upon Contact With Aqueous Solutions Such As Blood Or Saline, Precipitates In Situ Forming A Spongy/ |
| Technical Method | Intravascular Embolization |
| Target Area | Intracranial Aneurysms As Specified By Indication Statement |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | OBA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3855 |
| Device | Polymerizing, Neurovascular Embolization Material |
| Product Code | OBA |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |