PMA P160001S016
- Device
- Obalon Balloon Kit
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S016
- Product code
- LTI
- Decision date
- 2018-05-31
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Change in the adhesive dispensing process by adding an alternate syringe piston.
Current openFDA PMA Record#
- Device
- Obalon Balloon Kit
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S016
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2018-05-31
- Decision code
- OK30
- Date received
- 2018-05-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the adhesive dispensing process by adding an alternate syringe piston.