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    Boston Scientific Corporation

    Boston Scientific Corporation
    780 Brookside Drive
    Spencer
    47460
    USA
    BSI logo

    Certificate number: MD 670368
    Scope: Manufacture of devices in the areas of Peripheral (including Peripheral Interventions), Electrosurgical Applications (including Electrophysiology), Gastroenterology, Nephrology, Gynecology, Urology, Radiology, Endoscopy, Biliary, General Surgery (including Minimally Invasive Surgical Procedures). These products include: Surgical meshes, 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, examination gloves, irrigation/drainage devices and sets, fluid administration and infusion devices, inflators, ligators, dilators, connecting tubes, access sheaths adaptors; percutaneous access needles, aspiration needles, injection needles, introducer needles, endotherapy electrode system; syringes, vascular introducers, nephrostomy devices, guidewires, biopsy devices, polypectomy devices, hemostasis devices, torque devices, cuff kits, biopsy caps, locking devices, bladder evacuators and sphincterotomes. The manufacture of medical device accessories for use with implantable cardioverter defibrillators, including implantable cardiac defibrillation leads.

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

    Certificate number: MDSAP 672104
    Scope: Manufacture of devices in the areas of Peripheral (including Peripheral Interventions), Electrosurgical Applications (including Electrophysiology), Gastroenterology, Nephrology, Gynecology, Urology, Radiology, Endoscopy, Biliary, General Surgery (including Minimally Invasive Surgical Procedures). These products include: Surgical meshes, 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, examination gloves, irrigation/drainage devices and sets, fluid administration and infusion devices, inflators, ligators, dilators, connecting tubes, access sheaths adaptors; percutaneous access needles, aspiration needles, injection needles, introducer needles, endotherapy electrode system; syringes, vascular introducers, nephrostomy devices, guidewires, biopsy devices, polypectomy devices, hemostasis devices, torque devices, cuff kits, biopsy caps, locking devices, bladder evacuators and sphincterotomes. The manufacture of medical device accessories for use with implantable cardioverter defibrillators, including implantable cardiac defibrillation leads.

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