PMA P100018

Device: Pipeline™ Flex Embolization Device with Shield Technology™ (Pipeline™ Shield); Pipeline™ Vantage Embolization Device wit
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S037
Product code: OUT
Decision date: 2026-06-26
Generic name: Intracranial aneurysm flow diverter
Approval order statement: approval to remove the X-ray Photelectron Spectroscopy (XPS) testing and its associated Statistical Process Control (SPC) recording for the application of Shield Technology to the Pipeline braid and additional enhanced process controls, including minimum fill height verification and the addition of a 9 mm guard band

Current openFDA PMA Record#

Device: Pipeline™ Flex Embolization Device with Shield Technology™ (Pipeline™ Shield); Pipeline™ Vantage Embolization Device wit
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S054
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2026-06-26
Decision code: OK30
Date received: 2026-05-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to remove the X-ray Photelectron Spectroscopy (XPS) testing and its associated Statistical Process Control (SPC) recording for the application of Shield Technology to the Pipeline braid and additional enhanced process controls, including minimum fill height verification and the addition of a 9 mm guard band