- Device
- ReShape Integrated Dual Balloon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S013
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2018-05-31
- Decision code
- APPR
- Date received
- 2018-05-02
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling updates to inform users about current risks associated with device use and adverse event information.