PMA P100018S050

Device: Pipeline Flex Embolization Device; Pipeline Flex Embolization Device with Shield Technology (Pipeline™ Shield)
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S050
Product code: OUT
Decision date: 2025-03-27
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: approval for a change in the vapor degreaser and vapor pressure used during the manufacturing of delivery system components

Current openFDA PMA Record#

Device: Pipeline Flex Embolization Device; Pipeline Flex Embolization Device with Shield Technology (Pipeline™ Shield)
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S050
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2025-03-27
Decision code: OK30
Date received: 2025-02-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a change in the vapor degreaser and vapor pressure used during the manufacturing of delivery system components