ReShape Integrated Dual Balloon System
FDA premarket approval P140012/S013 · decided 2018-05-31
Approval details
- PMA number
- P140012
- Supplement
- S013
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ReShape Integrated Dual Balloon System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Boston Scientific Corporation
- Date received
- 2018-05-02
- Decision date
- 2018-05-31
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Approval for labeling updates to inform users about current risks associated with device use and adverse event information.
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