- Device
- ORBERA INTRAGASTRIC BALLOON SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S003
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2016-05-23
- Decision code
- APPR
- Date received
- 2015-09-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a manufacturing site located at Apollo Endosurgery, Building 13.3, Zona Franca Coyol, Alajuela, Costa Rica