Obalon Balloon Kit
FDA premarket approval P160001/S015 · decided 2018-06-22
Approval details
- PMA number
- P160001
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Obalon Balloon Kit
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2018-04-23
- Decision date
- 2018-06-22
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Approval for a design change in the Proximal Luer Hub and subsequent supplier change.
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