Obalon Balloon System
FDA premarket approval P160001/S042 · decided 2019-08-08
Approval details
- PMA number
- P160001
- Supplement
- S042
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Obalon Balloon System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2019-06-14
- Decision date
- 2019-08-08
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Approval of the revised protocol for the post-approval study protocol.The Obalon Balloon System Post-Approval Study is a prospective, open-label, single-arm study of the safety and effectiveness of the Obalon 6-month Balloon System, as an adjunct to weight loss for obese adults 22 years of age and older with a Body Mass Index (BMI) of 30 kg/m2 to 40 kg/m2. This is a 12-month follow-up study in which subjects will be treated during the first 6 months with placement (via swallow) of up to three Ob
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