OBA — Polymerizing, Neurovascular Embolization Material Class f
FDA product code OBA covers "Polymerizing, Neurovascular Embolization Material", a Class f medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- OBA
- Device Class
- Class f
- Regulation Number
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Unknown
- Implant
- Yes
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.