PMA P100018S023

Device: Pipeline Flex Embolization Device
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S023
Product code: OUT
Decision date: 2019-09-20
Classification: Intracranial Aneurysm Flow Diverter
Generic name: Intracranial aneurysm flow diverter
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.

Current openFDA PMA Record#

Device: Pipeline Flex Embolization Device
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S023
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2019-09-20
Decision code: OK30
Date received: 2019-08-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.