PMA P160001S015
- Device
- Obalon Balloon Kit
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S015
- Product code
- LTI
- Decision date
- 2018-06-22
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for a design change in the Proximal Luer Hub and subsequent supplier change.
Current openFDA PMA Record#
- Device
- Obalon Balloon Kit
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S015
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2018-06-22
- Decision code
- APPR
- Date received
- 2018-04-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change in the Proximal Luer Hub and subsequent supplier change.