Obalon Touch Inflation System
FDA premarket approval P160001/S007 · decided 2018-09-25
Approval details
- PMA number
- P160001
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Obalon Touch Inflation System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2017-11-01
- Decision date
- 2018-09-25
- Days to decision
- 328 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Approval for the Obalon Touch Inflation System (as an alternative to the EzFill Inflation System) to be used with the Obalon Balloon System.
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