|
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 | S024 |
Date Received | 03/10/2020 |
Decision Date | 10/05/2020 |
Product Code |
OUT
|
Advisory Committee |
Neurology |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | labeling change - pas |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Approval for labeling changes to incorporate completed results from the post-approval study (PAS) titled Prospective Study on Embolization of Intracranial Aneurysms with Pipeline Embolization Device (PREMIER). |