ORBERA ® Intragastric Balloon (IGB) System
FDA premarket approval P140008/S024 · decided 2022-10-05
Approval details
- PMA number
- P140008
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ORBERA ® Intragastric Balloon (IGB) System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Boston Scientific Corporation
- Date received
- 2022-07-11
- Decision date
- 2022-10-05
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Approval for a change to the physician labeling to update Table 21: ORBERA device- and procedure- related adverse events and complaints reported through clinical product surveillance.
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