Device |
material, embolization, neurovascular, polymerizing or precipitating |
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. |
Review Panel |
Neurology |
Product Code | NPE |
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? |
No
|
Life-Sustain/Support Device? |
Yes
|
Third Party Review |
Not Third Party Eligible |
|
|