PMA P160001S030
- Device
- Obalon Balloon System
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S030
- Product code
- LTI
- Decision date
- 2019-02-14
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for changes to physician and patient labeling in response to reported cases of gastric perforation.
Current openFDA PMA Record#
- Device
- Obalon Balloon System
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S030
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2019-02-14
- Decision code
- APPR
- Date received
- 2019-01-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to physician and patient labeling in response to reported cases of gastric perforation.