DUAL CHAMBER RATE RESPONSIVE PACEMAKER

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

5 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Model Catalog: C60A1 (Lot serial: >100 DEVICES); Model Catalog: T70A1 (Lot serial: CONTACT MANUFACTURER); Model Catalog: C60A1 (Lot serial: CONTACT MANUFACTURER); Model Catalog: T70A1 (Lot serial: >100 DEVICES); Model Catalog: T60A1 (Lot serial: CONTACT MANUFACTURER); Model Catalog: T60A1 (Lot serial: >10 DEVICES); Model Catalog: C50A1 (Lot serial: CONTACT MANUFACTURER); Model Catalog: C50A1 (Lot serial: >10 DEVICES); Model Catalog: C60A2U (Lot serial: >10 DEVICES); Model Catalog: C60A2U (Lot serial: CONTACT MANUFACTURER)
  • Description du dispositif
    see 33-01
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: P1501DR (Lot serial: >1000 NUMBERS); Model Catalog: P1501DR (Lot serial: MANUFACTURER); Model Catalog: P1501DR (Lot serial: CONTACT)
  • Description du dispositif
    ENRHYTHM DUAL CHAMBER RATE RESPONSIVE PACEMAKER
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: VEDR01 (Lot serial: >10 contact manufacturer); Model Catalog: KDR906 (Lot serial: >10 contact manufacturer); Model Catalog: E2D03 (Lot serial: >10 contact manufacturer); Model Catalog: KDR931 (Lot serial: >10 contact manufacturer); Model Catalog: KDR903 (Lot serial: >10 contact manufacturer); Model Catalog: KDR933 (Lot serial: >10 contact manufacturer); Model Catalog: KDR803 (Lot serial: >10 contact manufacturer); Model Catalog: E2DR33 (Lot serial: >10 contact manufacturer); Model Catalog: E2DR31 (Lot serial: >10 contact manufacturer); Model Catalog: E2DR21 (Lot serial: >10 contact manufacturer); Model Catalog: E2DR06 (Lot serial: >10 contact manufacturer); Model Catalog: E2DR03 (Lot serial: >10 contact manufacturer); Model Catalog: E2DR01 (Lot serial: >10 contact manufacturer); Model Catalog: KD703 (Lot serial: >10 contact manufacturer); Model Catalog: PHM621259S (Lot serial: >10 contact manufacturer); Model Catalog: REVDD01 (Lot serial: >10 contact manufacturer); Model Catalog: KDR706 (Lot s
  • Description du dispositif
    VERSA DUAL CHAMBER RATE RESPONSIVE PACEMAKER
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: E2DR31 (Lot serial: PNL615048S); Model Catalog: E2DR31 (Lot serial: PNL615066S); Model Catalog: E2DR31 (Lot serial: PNL615043S); Model Catalog: E2DR31 (Lot serial: PNL615028S)
  • Description du dispositif
    SEE 33-01
  • Manufacturer
  • Modèle / numéro de série
    All lots/serial numbers
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    within the US to include: AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, NC, ND, NJ, NY, OH, OK, SC, TX.
  • Description du dispositif
    Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C60A1 and C60A3. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing using an accelerometer) for permanent atrial and ventricular pacing. C-series software is VSF11/VSF12 Version 1.0. Vitatron is a division of Medtronic, Inc., Sales Office is Vitatron USA, 7000 Central Ave., NE, Minneapolis, MN 55423-3576. The head office is Vitatron B.V., P.O. Box 5227, 6802 EE Arnhem, The Netherlands.
  • Manufacturer