- Device
- ORBERA INTRAGASTRIC BALLOON
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S028
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2026-01-05
- Decision code
- APPR
- Date received
- 2025-11-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing site change to replace the Apollo Endosurgery Coyol, Costa Rica facility with the Boston Scientific Coyol, Costa Rica facility for the Orbera Intragastric Balloon, following acquisition of Apollo Endosurgery by Boston Scientific