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Health Sciences Authority
Dear Healthcare Professional Letters

Update to the Instruction For Use (IFU) of Endologix Nellix® EndoVascular Aneurysm Sealing System

Audiences

Healthcare professional

Product type

Medical devices

1 November 2017

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Somnotec (S) Pte Ltd would like to inform healthcare professionals of updates to a field safety notice of Nellix® EndoVascular Aneurysm Sealing System (Nellix System) on revisions to its Instructions For Use (IFU). The updates include the current data available to support the refined IFU and patient selection criteria, options for secondary interventions in patients who have specific Nellix-related complication and information related to off-label use of the Nellix System. No product return is required as a result of this notification. Please refer to the letter for details. 


Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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