Obalon Balloon System
FDA premarket approval P160001/S030 · decided 2019-02-14
Approval details
- PMA number
- P160001
- Supplement
- S030
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Obalon Balloon System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2019-01-18
- Decision date
- 2019-02-14
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Approval for changes to physician and patient labeling in response to reported cases of gastric perforation.
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