PMA P100018S049

Device: Pipeline™ Vantage Embolization Device with Shield Technology™ (Pipeline™ Vantage)
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S049
Product code: OUT
Decision date: 2025-03-05
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: Approval for changes to the Instructions for Use (IFU) for the Pipeline Vantage to clarify procedural steps for using the Pipeline Vantage and to provide additional information for the safe use of the device.

Current openFDA PMA Record#

Device: Pipeline™ Vantage Embolization Device with Shield Technology™ (Pipeline™ Vantage)
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
PMA number: P100018
Supplement: S049
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2025-03-05
Decision code: APPR
Date received: 2025-02-03
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for changes to the Instructions for Use (IFU) for the Pipeline Vantage to clarify procedural steps for using the Pipeline Vantage and to provide additional information for the safe use of the device.