PMA P140008S011
- Device
- Orbera Intragastric Balloon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S011
- Product code
- LTI
- Decision date
- 2018-01-12
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for two additional inspections to the manufacture of the vulcanized balloon.
Current openFDA PMA Record#
- Device
- Orbera Intragastric Balloon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S011
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2018-01-12
- Decision code
- APPR
- Date received
- 2017-12-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for two additional inspections to the manufacture of the vulcanized balloon.