Obalon Balloon System
FDA premarket approval P160001/S022 · decided 2018-10-01
Approval details
- PMA number
- P160001
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Obalon Balloon System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2018-09-06
- Decision date
- 2018-10-01
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Addition of a cleaning step for a component manufacturing process.
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