|
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 | S019 |
Date Received | 11/29/2018 |
Decision Date | 12/27/2018 |
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
Change to allow sterile product to be released based on parametric release, rather than conventional release at the contract sterilization site (Sterigenics US LLC). |