Pinnacle Pelvic Floor Repair Kit

Fabricant

  • 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
    SATP

4 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
  • Description du dispositif
    medical_device
  • Manufacturer
  • Modèle / numéro de série
    Catalog/UPC: M0068317100, Lot: 1ML0072001. Catalog/UPC M0068317050, Lot: 1ML0070801.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution; (USA) Nationwide distribution, and the countries of Puerto Rico, France, Great Britain, Ireland, Italy, Spain, Sweden, Canada, and Australia.
  • Description du dispositif
    Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE. || Boston Scientific, Corp. || Indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
  • Manufacturer
  • Modèle / numéro de série
    M0068317050 | ML00000034
  • Description du dispositif
    MD: Surgical mesh kit; Laser beam delivery unit, fibreoptic; Ligation clip, metallic
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: M0068317050 (Lot serial: 1ML0070801)
  • Description du dispositif
    PINNACLE PELVIC FLOOR REPAIR KIT
  • Manufacturer