|
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. |