PMA P140008S023
- Device
- ORBERA® Intragastric Balloon (IGB) System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S023
- Product code
- LTI
- Decision date
- 2021-12-21
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Manufacturing changes to the sheath assembly procedures.
Current openFDA PMA Record#
- Device
- ORBERA® Intragastric Balloon (IGB) System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S023
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2021-12-21
- Decision code
- OK30
- Date received
- 2021-12-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing changes to the sheath assembly procedures.