NPE — Material, Embolization, Neurovascular, Polymerizing Or Precipitating Class III
FDA product code NPE covers "Material, Embolization, Neurovascular, Polymerizing Or Precipitating", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- NPE
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Unknown
- Implant
- No
Definition
This is an neurovascular embolization device which is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation. It is unlike the coil or particulate embolization devices in that it polymerizes or precipitates in situ. Particulate or coil-based embolic agents are delivered in pre-formed shapes and configurations.