PMA P140008S005
- Device
- ORBERA Intragastric Balloon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S005
- Product code
- LTI
- Decision date
- 2017-05-01
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Addition of a new supplier of a device component.
Current openFDA PMA Record#
- Device
- ORBERA Intragastric Balloon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S005
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2017-05-01
- Decision code
- OK30
- Date received
- 2017-04-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new supplier of a device component.