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    Boston Scientific Corporation

    Boston Scientific Corporation
    4100 Hamline Ave. N.
    St. Paul
    55112
    USA
    BSI logo

    Certificate number: MD 670368
    Scope: Design and development of medical devices in the areas of Electrosurgical Applications (including Electrophysiology, Urology), cardiovascular and minimally invasive surgical and interventional procedures. These products include: cardiac ablation catheters, diagnostic mapping, pacing and recording catheters, generator equipment, cables, fluid filling devices, electrosurgical instruments and generators pericardiocentesis kits, tubing sets, fluid circulation pumps, and diagnostic software and recording systems inclusive of accessory devices. Design, manufacture, distribution, service and refurbishment of electrophysiology recording and mapping systems and software inclusive of accessory devices. Manufacture of electrosurgical instruments and generators. Manufacture, distribution and service of cardiac ablation systems inclusive of accessory devices. Distribution of urological devices such as generators and software for generators. Manufacture and service of medical laser systems and accessories. Manufacture and sterilization of penile prosthesis and associated accessories and surgical tools, implants for incontinence and associated accessories and surgical tools. Manufacture, installation, service and distribution of atherectomy angioplasty devices systems and accessories and minimally invasive tissue and thrombus removal devices. Manufacture, distribution, service and installation of ultrasound imaging systems inclusive of accessory devices. Manufacture and service of medical device electronic systems associated with diagnostics, monitoring, and therapy. Manufacture, service and distribution of Endoscope systems and accessories.

    Standard/Scheme number or name Start Date Expiry Date
    ISO 13485: 2016 2017-05-08 2026-09-01

    Certificate number: MDSAP 672104
    Scope: Design and development of medical devices in the areas of Electrosurgical Applications (including Electrophysiology, Urology), cardiovascular and minimally invasive surgical and interventional procedures. These products include: cardiac ablation catheters, diagnostic mapping, pacing and recording catheters, generator equipment, cables, fluid filling devices, electrosurgical instruments and generators pericardiocentesis kits, tubing sets, fluid circulation pumps, and diagnostic software and recording systems inclusive of accessory devices. Design, manufacture, distribution, service and refurbishment of electrophysiology recording and mapping systems and software inclusive of accessory devices. Manufacture of electrosurgical instruments and generators. Manufacture, distribution and service of cardiac ablation systems inclusive of accessory devices. Distribution of urological devices such as generators and software for generators. Manufacture and service of medical laser systems and accessories. Manufacture and sterilization of penile prosthesis and associated accessories and surgical tools, implants for incontinence and associated accessories and surgical tools. Manufacture, installation, service and distribution of atherectomy angioplasty devices systems and accessories and minimally invasive tissue and thrombus removal devices. Manufacture, distribution, service and installation of ultrasound imaging systems inclusive of accessory devices. Manufacture and service of medical device electronic systems associated with diagnostics, monitoring, and therapy. Manufacture, service and distribution of Endoscope systems and accessories.

    Standard/Scheme number or name Start Date Expiry Date
    MDSAP 2018-02-21 2026-09-01