DevicePMAs@therightstef:P070009_S003 / 0-5
|
Approval for a line extension to the realize adjustable gastric bandthe device, as modified, will be marketed under the trade name realize adjustable gastricband curved (model bd3xv) and is indicated for weight reduction for morbidly obese patientsand is indicated for individuals with a body mass index (bmi) of at least 40 kg/m2, or a bmi ofat least 35 kg/m2 with one or more comorbid conditions. the band is indicated for use only inmorbidly obese adult patients who have failed more conservative weight-reduction alternatives,such as supervised diet, exercise and behavior modification programs.
|