PMA P160001S021
- Device
- Obalon Balloon System
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S021
- Product code
- LTI
- Decision date
- 2019-01-25
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval of the revised protocol that includes inflation can branding, a new timeline, product performance observations, a deviation log, an additional clinical site to be enrolled, and editorial modifications to avoid redundancy and add clarification as needed for the PAS protocol.
Current openFDA PMA Record#
- Device
- Obalon Balloon System
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S021
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2019-01-25
- Decision code
- APPR
- Date received
- 2018-09-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol that includes inflation can branding, a new timeline, product performance observations, a deviation log, an additional clinical site to be enrolled, and editorial modifications to avoid redundancy and add clarification as needed for the PAS protocol.