Material, Embolization, Neurovascular, Polymerizing Or Precipitating
NPE · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
NPE
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
NE
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
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.