| Device |
catheter, neuro-vasculature, occluding ballon |
| Regulation Description |
Intravascular occluding catheter. |
| 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. |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | NUF |
|---|
| Submission Type |
PMA
|
|---|
| Regulation Number |
882.5150
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
