Device |
intracranial aneurysm flow diverter |
Definition |
Treatment of wide-necked and larger or giant intracranial aneurysms. |
Physical State |
metallic |
Technical Method |
interventional |
Target Area |
neurovasculature |
Review Panel |
Neurology |
Product Code | OUT |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Third Party Review |
Not Third Party Eligible |