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FDA accepts 510(k) premarket notification filing for Xen treatment system

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The FDA has accepted the filing of the 510(k) premarket notification application for the Xen Glaucoma Treatment System, Allergan announced in a press release.

The system includes the Xen45, which is a minimally invasive gelatin shunt, and the Xen injector.

“We look forward to working together with the FDA to bring this treatment to market," David Nicholson, chief research and development officer at Allergan, said in the release.

Xen45 has received CE mark in the European Union and is licensed for use in Canada, Switzerland and Turkey.