Boston Scientific Watchman FLX™ Pro Left Atrial Appendage Closure Device with Delivery System - HSA Registration DE0510218
Access comprehensive regulatory information for Boston Scientific Watchman FLX™ Pro Left Atrial Appendage Closure Device with Delivery 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 DE0510218 and owned by Boston Scientific Coporation. The device was registered on January 08, 2025.
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.
WATCHMAN FLX Pro is intended for percutaneous, transcatheter closure of the left atrial appendage. The WATCHMAN FLX Pro Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who: • Are at increased risk for stroke and systemic embolism based on CHA2DS2-VASc1 scores and are recommended for anticoagulation therapy; • Are deemed by their physicians to be suitable for anticoagulation therapy; and • Have an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy.