PMA P140008S021
- Device
- ORBERA Intragastric Balloon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S021
- Product code
- LTI
- Decision date
- 2020-10-16
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for implementation of a new retention force specification and corresponding quality control inspection.
Current openFDA PMA Record#
- Device
- ORBERA Intragastric Balloon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S021
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2020-10-16
- Decision code
- APPR
- Date received
- 2020-09-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for implementation of a new retention force specification and corresponding quality control inspection.