Boston Scientific AVVIGO+ Multi-Modality Guidance Systems - HSA Registration DE0509503
Access comprehensive regulatory information for Boston Scientific AVVIGO+ Multi-Modality Guidance Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509503 and owned by Boston Scientific Corporation. The device was registered on July 09, 2024.
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 IVUS modality of the System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are stable and are candidates for transluminal interventional procedures such as angioplasty and atherectomy. FFR and DFR™ are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of stable patients with intermediate-grade stenosis that undergo measurement of physiological parameters.