Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: OBALON BALLOON SYSTEM
• Generic Name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Applicant: Medtimo, Inc.; 7625 Golden Triangle Dr.; Suite G; Eden Prairie, MN 55344
• PMA Number: P160001
• Date Received: 01/07/2016
• Decision Date: 09/08/2016
• Product Code: LTI
• Docket Number: 16M-2651
• Notice Date: 09/14/2016
• Advisory Committee: Gastroenterology/Urology
• Clinical Trials: NCT02235870
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the Obalon Balloon System. The device is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 to 40 kg/m2) who have failed to lose weight through diet and exercise. The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S005 S002 S003 S001 S008 S009 S010 S020 S021 S022 S014 ; S029 S044 S035 S036 S037 S038 S018 S019 S011 S007 S015 S016 ; S017 S013 S030 S031 S032 S033 S046 S039 S040 S041 S042 S043 ; S023 S024 S025 S026 S027 S028 S047