Obalon Balloon Sustem
FDA premarket approval P160001/S005 · decided 2017-03-09
Approval details
- PMA number
- P160001
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Obalon Balloon Sustem
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2017-03-02
- Decision date
- 2017-03-09
- Days to decision
- 7 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Approval for labeling changes have been requested by the Office of Surveillance and Biometrics, Signal Management Program as a result of a safety signal with fluid filled gastric balloons.
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