OBALON BALLOON SYSTEM
FDA premarket approval P160001/S003 · decided 2017-04-25
Approval details
- PMA number
- P160001
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OBALON BALLOON SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2016-11-16
- Decision date
- 2017-04-25
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Approval for the additional of a plant-based capsule material option.
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