PMA P160001S003
- Device
- OBALON BALLOON SYSTEM
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S003
- Product code
- LTI
- Decision date
- 2017-04-25
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for the additional of a plant-based capsule material option.
Current openFDA PMA Record#
- Device
- OBALON BALLOON SYSTEM
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S003
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2017-04-25
- Decision code
- APPR
- Date received
- 2016-11-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the additional of a plant-based capsule material option.