QCA · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
QCA
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
N
Implant
Y
Third-party review
N
Definition
An intracranial coil-assist stent is a tubular device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck intracranial aneurysms.