Obalon Balloon System
FDA premarket approval P160001/S021 · decided 2019-01-25
Approval details
- PMA number
- P160001
- Supplement
- S021
- 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
- 2018-09-05
- Decision date
- 2019-01-25
- Days to decision
- 142 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Approval of the revised protocol that includes inflation can branding, a new timeline, product performance observations, a deviation log, an additional clinical site to be enrolled, and editorial modifications to avoid redundancy and add clarification as needed for the PAS protocol.
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