Singapore HSA registration DE0510218

Boston Scientific Watchman FLX™ Pro Left Atrial Appendage Closure Device with Delivery System

Singapore·CLASS D·Boston Scientific Coporation·Registered January 08, 2025

Device classification

Device Class: CLASS D
Medical Speciality Area: Cardiovascular

Registration information

Registration Number: DE0510218
Registration Date: January 08, 2025
Retention Due Date: January 07, 2026

Product description

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.

Product Owner

Name: Boston Scientific Coporation
Short Name: Boston Scientific Coporation
Address: 300 Boston Scientific Way, Marlborough, MA01752-1234, UNITED STATES

Registrant

Name: BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address: 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588

Importer

Name: BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address: 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588

Model information

Model Name(s): Watchman FLX™ Pro Watchman FLX™ Pro Watchman FLX™ Pro Watchman FLX™ Pro Watchman FLX™ Pro Watchman FLX™ Pro
Model Identifier(s): M635WU60200 M635WU60240 M635WU60270 M635WU60310 M635WU60350 M635WU60400

About this record

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.

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