Singapore HSA registration DE0509503
Boston Scientific AVVIGO+ Multi-Modality Guidance Systems
Singapore·CLASS B·Boston Scientific Corporation·Registered July 09, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0509503
- Registration Date
- July 09, 2024
- Change Notification Approval Date
- December 03, 2024
- Retention Due Date
- July 08, 2025
Product description
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.
Product Owner
- Short Name
- Boston Scientific Corporation
- Address
- 300 Boston Scientific Way, Marlborough, MA 01752, UNITED STATES
Registrant
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Model information
- Model Name(s)
- AVVIGO™ + Multi-Modality Guidance System AVVIGO™ + Multi-Modality Guidance System (Refurbished) AVVIGO™ + Mobile System Multi-Modality Guidance System AVVIGO™ + Mobile System Multi-Modality Guidance System (Refurbished) AVVIGO™ + Integrated System Multi-Modality Guidance System AVVIGO™ + Integrated System Multi-Modality Guidance System (Refurbished) Permanent Sled Bag Permanent Sled MDU5 PLUS™ Sterile Bag MDU5 Plus Fast Pullback MDU5 Plus Fast Pullback (Refurbished)
- Model Identifier(s)
- H74924930220 H7492493022R0 (Refurbished) H7492493320C0 H7492493320CR0 (Refurbished) H7492493320I0 H7492493320IR0 (Refurbished) H749393150100 H749393160100 H749MDU5PLUSBAG0 H749MDU5PLUSF0 H749MDU5PLUSFR0 (Refurbished)
About this record
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.
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