Device Recall ReShape Integrated Dual Balloon System, Gen 1

  • Modelo / Serial
    160317-001, 160371-002, 160317-003, 160324-010.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    US: Distribution to the states of : NY, OH and CA.
  • Descripción del producto
    ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 || The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Reshape Medical Inc, 100 Calle Iglesia, San Clemente CA 92672-7502
  • Source
    USFDA