PMA P160001S009
- Device
- Obalon Balloon System
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S009
- Product code
- LTI
- Decision date
- 2018-01-26
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Modification to the proximal luer hub receiving inspection method and inspection sample size increase.
Current openFDA PMA Record#
- Device
- Obalon Balloon System
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S009
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2018-01-26
- Decision code
- OK30
- Date received
- 2018-01-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the proximal luer hub receiving inspection method and inspection sample size increase.