Obalon Balloon System with Navigation Touch
FDA premarket approval P160001/S020 · decided 2018-12-20
Approval details
- PMA number
- P160001
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Obalon Balloon System with Navigation Touch
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2018-07-31
- Decision date
- 2018-12-20
- Days to decision
- 142 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Approval for the use of the Obalon Navigation-Touch System for administration of the Obalon Balloon System.
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