Obalon Ballon System with Navigation and Touch
FDA premarket approval P160001/S044 · decided 2020-02-11
Approval details
- PMA number
- P160001
- Supplement
- S044
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Obalon Ballon System with Navigation and Touch
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2019-11-13
- Decision date
- 2020-02-11
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Approval for a modification to the software of the Obalon Navigation Console.
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