|
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 | S028 |
Date Received | 08/24/2020 |
Decision Date | 09/21/2020 |
Product Code |
OUT
|
Advisory Committee |
Neurology |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Approval for labeling changes to the instructions for use to strengthen information about possible device component separation, fracture, or breakage in the warnings, cautions and potential complications sections. |