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    Boston Scientific Corporation

    Boston Scientific Corporation
    100 Boston Scientific Way
    Marlborough
    01752
    USA
    BSI logo

    Certificate number: MD 670368
    Scope: Design and development of devices in the areas of Gastroenterology, Nephrology, Gynecology, Urology, Endoscopy, Biliary and General Surgery (including Minimally Invasive Surgical Procedures). These products include: biliary stents, ureteral stents, pancreatic stents, drainage catheters, introducer catheters, urological catheters, percutaneous catheters and guide catheters, biliary devices, retrieval devices, feeding devices, cannulas, endoscopes, irrigation/drainage devices and sets, fluid administration and infusion devices, inflators, ligators, dilators, connecting tubes, adaptors, access sheaths, percutaneous access needles, aspiration needles, injection needles, endotherapy electrode systems, fiber optic laser delivery devices, sutures and suturing devices, nephrostomy devices, guidewires, biopsy devices, surgical mesh, polypectomy devices, hemostasis devices, torque devices, endoscopic valves, endoscope channel support kits, biopsy caps, locking devices, bladder evacuators and sphincterotomes, penile prosthesis implants for continence, accessories and surgical tools, medical laser systems and accessories. Design of implantable silicone obesity devices.

    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 devices in the areas of Gastroenterology, Nephrology, Gynecology, Urology, Endoscopy, Biliary and General Surgery (including Minimally Invasive Surgical Procedures). These products include: biliary stents, ureteral stents, pancreatic stents, drainage catheters, introducer catheters, urological catheters, percutaneous catheters and guide catheters, biliary devices, retrieval devices, feeding devices, cannulas, endoscopes, irrigation/drainage devices and sets, fluid administration and infusion devices, inflators, ligators, dilators, connecting tubes, adaptors, access sheaths, percutaneous access needles, aspiration needles, injection needles, endotherapy electrode systems, electrosurgical instruments and generators, fiber optic laser delivery devices, sutures and suturing devices, nephrostomy devices, guidewires, biopsy devices, surgical mesh, polypectomy devices, hemostasis devices, torque devices, endoscopic valves, endoscope channel support kits, biopsy caps, locking devices, bladder evacuators and sphincterotomes, penile prosthesis implants for continence, accessories and surgical tools, medical laser systems and accessories. Design of implantable silicone obesity devices.

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