Boston Scientific Neuromodulation Corporation

  • Adresse du fabricant
    Boston Scientific Neuromodulation Corporation, 25155 Rye Canyon Loop, Valencia CA 91355-5004
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
  • 1 Event

Un dispositif médical dans la base de données

  • Modèle / numéro de série
    SERIAL #'s: 27059297H, 46080743H, 46080918H, 56066331H, 56069528H, 56069671H, 56069673H, 56069686H, 56072440H, 56072655H, 56072666H, 56072674H, 57014750H, 57014755H, 57014757H, 66084643H, 77048447H, 87040459H, 87040630H, 87040942H, 87040947H, 87040951H, 87040957H, 87042729H, 87042732H, 87043106H, 87043119H, 87058615H 87058616H, 87058618H, 87058849H, 87059667H, 87082650H, 87082900H, 87086049H, 87094579H, 87094580H, 87094590H, 87094593H, 87094596H, 87094597H, 87094738H, 96026241Hu, 96026251Hu, 97045074H, 97047825H, 97072474H, 97076337H, 97076339H, 97076666H, 97076671H, 97076770H, 97079617H, 97081025H, 97081842H, X6090220H, X6098238H, X6099082H, X7021190H, X7087236H, Z7014824H, Z7060102H
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Domestically to AR, CA, CO, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NY, OH, OR, PA, PR, SC, TX, VA, WI Internationally: Italy
  • Description du dispositif
    Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4

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