Product code OBA

Device name

Polymerizing, Neurovascular Embolization Material

Medical specialty

Unknown

Device class

f

Review panel

NE

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset