Obalon Balloon System with Navigation and Touch
FDA premarket approval P160001/S031 · decided 2019-07-05
Approval details
- PMA number
- P160001
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Obalon Balloon System with Navigation and Touch
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2019-01-18
- Decision date
- 2019-07-05
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Approval for The Obalon Navigation Touch System (NTS) Post-Approval Study. The study is a prospective, observational, open-label, multi-center study designed to evaluate the risk of esophageal inflation during Obalon balloon administration in eligible patients. This is a stand-alone, new enrollment study with primary data collection, with no retrospective data acquisition from other sources (i.e., retrospective chart review; data abstraction from existing registries or other data sources). Safet
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