ORBERA Intragastric Balloon System
FDA premarket approval P140008/S016 · decided 2020-02-13
Approval details
- PMA number
- P140008
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ORBERA Intragastric Balloon System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-01-28
- Decision date
- 2020-02-13
- Days to decision
- 381 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Approval for changes to the material of the sheath and fill tube device components, change in the suppliers of the fill tube device component, design changes to the sheath component of the device, removal of the guidewire component of the fill tube, change in the manufacturing process of the sheath component of the device, packaging changes, and labeling changes.
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