Orbera® Intragastric Balloon (IGB) System
FDA premarket approval P140008/S027 · decided 2025-07-11
Approval details
- PMA number
- P140008
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Orbera® Intragastric Balloon (IGB) System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Boston Scientific Corporation
- Date received
- 2025-04-30
- Decision date
- 2025-07-11
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- minor labeling and design requirement changes associated with the integration of the Orbera Intragastric Balloon into the Boston Scientific quality system.
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