PMA P140008S018
- Device
- ORBERA Intragastric Balloon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S018
- Product code
- LTI
- Decision date
- 2019-07-19
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Additional supplier for the balloon shell and sheath components of your device and changing bioburden alert and action limits.
Current openFDA PMA Record#
- Device
- ORBERA Intragastric Balloon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S018
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2019-07-19
- Decision code
- OK30
- Date received
- 2019-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional supplier for the balloon shell and sheath components of your device and changing bioburden alert and action limits.