NUF · Class III — High Risk (PMA approval required, life-sustaining) · Neurology · 21 CFR 882.5150
Classification
FDA Product Code
NUF
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 882.5150
Review panel
NE
Medical specialty
Neurology
Submission type
2
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
Definition
Call for PMAs - 12/26/96 per 61 FR 50708 on 9/27/96 - For the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management