PMA P100018S052

Device: PIPELINE EMBOLIZATION DEVICE
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S052
Product code: OUT
Decision date: 2026-02-20
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: Approval of claims regarding reduced material thrombogenicity of a proprietary surface modification for the Pipeline™ Flex Embolization Device with Shield Technology™ and Pipeline™ Vantage Embolization Device with Shield Technology™ supported by acute benchtop in-vitro testing.

Current openFDA PMA Record#

Device: PIPELINE EMBOLIZATION DEVICE
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S052
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2026-02-20
Decision code: APPR
Date received: 2025-11-20
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval of claims regarding reduced material thrombogenicity of a proprietary surface modification for the Pipeline™ Flex Embolization Device with Shield Technology™ and Pipeline™ Vantage Embolization Device with Shield Technology™ supported by acute benchtop in-vitro testing.