PMA P140008S026
- Device
- ORBERA Intragastric Balloon
- Applicant
- Boston Scientific Corporation
- Product code
- LTI
- Decision date
- 2024-05-31
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- automatization of the sheath slitting process
Current openFDA PMA Record
- Device
- ORBERA Intragastric Balloon
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S026
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2024-05-31
- Decision code
- OK30
- Date received
- 2024-05-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- automatization of the sheath slitting process