FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Endologix Receives CE Mark for Nellix EndoVascular Aneurysm Sealing System

Oct. 2, 2017

Endologix received a CE Mark for its Nellix EndoVascular aneurysm sealing system with refined indications for use.

The Company’s notified body and an independent clinical reviewer determined in a review that Nellix, with refined indications for use, meets the applicable safety and clinical performance requirements.

Nellix is also being studied in the U.S. under an Investigational Device Exemption.

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