Device |
intrasaccular flow disruption device |
Definition |
An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach. |
Physical State |
A metal mesh-like implant attached to a delivery system. |
Technical Method |
An intrasaccular flow disruption device is a prescription use only device used to treat wide-neck intracranial aneurysms. The device is delivered into the neurovasculature with an endovascular approach, implanted within the sac of the intracranial aneurysm, and covers the neck of the intracranial aneurysm to obstruct blood from entering the intracranial aneurysm sac. |
Target Area |
Neurovasculature, intracranial aneurysms. |
Review Panel |
Neurology |
Product Code | OPR |
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
|
Third Party Review |
Not Third Party Eligible |