DevicePMAs@therightstef:P140012_S000 JSONTXT

Approval for the reshape integrated dual balloon system. 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.