Reshape Integrated Dual Balloon System

FDA premarket approval P140012 · Implant, Intragastric for Morbid Obesity

PMA numberP140012

Approval

Applicant
Boston Scientific Corporation
Received
July 1, 2014
Decision date
July 28, 2015 (APWD)
Supplements
13, latest May 31, 2018
Product code
LTI – Implant, Intragastric For Morbid Obesity

Official FDA PMA record

Approval order statement

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.