PMA P140008S007
- Device
- Orbera Intragastric Balloon
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S007
- Product code
- LTI
- Decision date
- 2017-08-21
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Orbera Intragastric Balloon
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S007
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2017-08-21
- Decision code
- APPR
- Date received
- 2017-05-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval for revised protocol for the post-approval study (PAS) protocol.