PMA P160001S020
- Device
- Obalon Balloon System with Navigation Touch
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S020
- Product code
- LTI
- Decision date
- 2018-12-20
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for the use of the Obalon Navigation-Touch System for administration of the Obalon Balloon System.
Current openFDA PMA Record#
- Device
- Obalon Balloon System with Navigation Touch
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S020
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2018-12-20
- Decision code
- APPR
- Date received
- 2018-07-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the use of the Obalon Navigation-Touch System for administration of the Obalon Balloon System.