PMA P160001S044
- Device
- Obalon Ballon System with Navigation and Touch
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S044
- Product code
- LTI
- Decision date
- 2020-02-11
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for a modification to the software of the Obalon Navigation Console.
Current openFDA PMA Record#
- Device
- Obalon Ballon System with Navigation and Touch
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S044
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2020-02-11
- Decision code
- APPR
- Date received
- 2019-11-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification to the software of the Obalon Navigation Console.