PMA P160001S007
- Device
- Obalon Touch Inflation System
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S007
- Product code
- LTI
- Decision date
- 2018-09-25
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for the Obalon Touch Inflation System (as an alternative to the EzFill Inflation System) to be used with the Obalon Balloon System.
Current openFDA PMA Record#
- Device
- Obalon Touch Inflation System
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S007
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2018-09-25
- Decision code
- APPR
- Date received
- 2017-11-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Obalon Touch Inflation System (as an alternative to the EzFill Inflation System) to be used with the Obalon Balloon System.