PMA P140008S013
- Device
- ORBERA Intragastric Balloon
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S013
- Product code
- LTI
- Decision date
- 2018-08-17
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for the ORBERA Intragastric Balloon System. The device 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.
Current openFDA PMA Record#
- Device
- ORBERA Intragastric Balloon
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S013
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2018-08-17
- Decision code
- APPR
- Date received
- 2018-06-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the ORBERA Intragastric Balloon System. The device is indicated for use as an adjunct to weight reduction for adults with obesity with Body Mass Index (BMI) of >= 30 and