Obalon Balloon System
FDA premarket approval P160001/S047 · decided 2022-07-18
Approval details
- PMA number
- P160001
- Supplement
- S047
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Obalon Balloon System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2022-01-19
- Decision date
- 2022-07-18
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Approval of the labeling reflecting the findings of the post-approval study (PAS) protocol.
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