PMA P140008S022
- Device
- ORBERA Intragastric Balloon (IGB) System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S022
- Product code
- LTI
- Decision date
- 2021-08-12
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for a change in the material used to manufacture the fill tube component.
Current openFDA PMA Record#
- Device
- ORBERA Intragastric Balloon (IGB) System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S022
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2021-08-12
- Decision code
- APPR
- Date received
- 2021-05-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the material used to manufacture the fill tube component.