Orbera Intragastric Balloon
FDA premarket approval P140008 · Implant, Intragastric for Morbid Obesity
PMA numberP140008
Approval
- Applicant
- Boston Scientific Corporation
- Received
- April 29, 2014
- Decision date
- August 5, 2015 (APPR)
- Supplements
- 23, latest January 5, 2026
- Product code
- LTI – Implant, Intragastric For Morbid Obesity
Approval order statement
APPROVAL FOR THE ORBERA INTRAGASTRIC BALLOON. THE ORBERA INTRAGASTRIC BALLOON SYSTEM IS INDICATED FOR USE AS AN ADJUNCT TO WEIGHT REDUCTION FOR ADULTS WITH OBESITY WITH BODY MASS INDEX (BMI) OF >= 30 AND <= 40 KG/M2 AND IS TO BE USED IN CONJUNCTION WITH A LONG-TERM SUPERVISED DIET AND BEHAVIOR MODIFICATION PROGRAM DESIGNED TO INCREASE THE POSSIBILITY OF SIGNIFICANT LONG-TERM WEIGHT LOSS AND MAINTENANCE OF THAT WEIGHT LOSS. ORBERA IS INDICATED FOR ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS. THE MAXIMUM PLACEMENT PERIOD FOR ORBERA IS 6 MONTHS.