PMA P140008S002
- Device
- ORBERA INTRAGASTRIC BALLOON SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S002
- Product code
- LTI
- Decision date
- 2016-02-26
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval of the post-approval study protocol.
Current openFDA PMA Record#
- Device
- ORBERA INTRAGASTRIC BALLOON SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S002
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2016-02-26
- Decision code
- APPR
- Date received
- 2015-09-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of the post-approval study protocol.