IN.PACT AMPHIRION PACLITAXEL-ELUTING PTA BALLOON CATHETER

  • Modèle / numéro de série
    Model Catalog: AMD 020 120 15P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 025 040 00P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 020 080 15P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 020 080 00P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 020 040 15P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 020 040 00P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 040 120 15P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 040 120 00P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 040 080 15P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 040 080 00P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 040 040 15P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 035 120 15P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 035 080 15P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 035 040 15P (Lot serial: >10 numbers contact mfg); Model Catalog: AMD 030 120 15P (Lot serial:
  • Description du dispositif
    IN.Pact Amphirion drug-eluting balloon (DEB)
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    BRAMPTON
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC