PMA P160001S023
- Device
- Obalon Balloon System
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S023
- Product code
- LTI
- Decision date
- 2018-10-05
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Addition of a component inspection step in the manufacturing process.
Current openFDA PMA Record#
- Device
- Obalon Balloon System
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S023
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2018-10-05
- Decision code
- OK30
- Date received
- 2018-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a component inspection step in the manufacturing process.