PMA P160001S008
- Device
- Obalon Balloon System
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S008
- Product code
- LTI
- Decision date
- 2018-10-25
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for adding an alternate adhesive supplier and adding an inflation gas supplier.
Current openFDA PMA Record#
- Device
- Obalon Balloon System
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S008
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2018-10-25
- Decision code
- APPR
- Date received
- 2018-01-04
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for adding an alternate adhesive supplier and adding an inflation gas supplier.