|
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 | S023 |
Date Received | 08/22/2019 |
Decision Date | 09/20/2019 |
Product Code |
OUT
|
Advisory Committee |
Neurology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Changes to the packaging operations of the Pipeline Flex Embolization Device, including the addition of a new pouch heat sealer and replacing quality control visual inspections with equivalent in-line inspections. |