Stryker Neurovascular Wingspan Stent System - HSA Registration DE0018597
Access comprehensive regulatory information for Stryker Neurovascular Wingspan Stent System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0018597 and owned by Stryker Neurovascular. The device was registered on September 26, 2016.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Wingspan Stent System with Gateway PTA Balloon Catheter is indicated for use in improving cerebral artery lumen diameter in patients 22 to 80 years old with recurrent (2 or more) strokes refractory to a comprehensive regimen of medical therapy and due to atherosclerotic disease of intracranial vessels with 70-99% stenosis that are accessible to the system. The most recent stroke must have occurred more than 7 days prior to treatment with the Wingspan Stent System. Patients are eligible for treatment with the Wingspan Stent System if their Modified Rankin Score (mRS) is 3 or less at the time of treatment.