HSA · registration DE0509503Boston Scientific AVVIGO+ Multi-Modality Guidance Systems
- Registration number
- DE0509503
- Model name
- 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
- H74924930220; H7492493022R0 (Refurbished); H7492493320C0; H7492493320CR0 (Refurbished); H7492493320I0; H7492493320IR0 (Refurbished); H749393150100; H749393160100; H749MDU5PLUSBAG0; H749MDU5PLUSF0; H749MDU5PLUSFR0 (Refurbished)
- Registration date
- July 09, 2024
- Source update date
- December 03, 2024
- Risk class
- Class B
- Product owner
- Boston Scientific Corporation
- Registrant / registration holder
- BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
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 address
- 300 Boston Scientific Way, Marlborough, MA 01752, UNITED STATES
- Registrant address
- 9 NORTH BUONA VISTA DRIVE, #20-01, THE METROPOLIS, Singapore 138588
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.