|
Device | Pipeline Flex Embolization Device |
Generic Name | intracranial aneurysm flow diverter |
Applicant |
Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR |
9775 toledo way |
irvine, CA 92618 |
|
PMA Number | P100018 |
Supplement Number | S015 |
Date Received | 06/28/2017 |
Decision Date | 12/14/2018 |
Product Code |
OUT
|
Docket Number | 18M-4779 |
Notice Date | 01/25/2019 |
Advisory Committee |
Neurology |
Supplement Type | panel track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Approval for the Pipeline Flex Embolization Device to expand the indications for use to include use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width >= 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter >= 2.0 mm and <= 5.0 mm. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
|