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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceOBALON BALLOON SYSTEM
Classification Nameimplant, intragastric for morbid obesity
Generic Nameimplant, intragastric for morbid obesity
Applicant
OBALON THERAPEUTICS, INC.
5421 avenida encinas
suite f
carlsbad, CA 92008
PMA NumberP160001
Date Received01/07/2016
Decision Date09/08/2016
Product Code
LTI[ Registered Establishments with LTI ]
Docket Number 16M-2651
Notice Date 09/14/2016
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT02235870
Expedited Review Granted? No
Combination Product 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 StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S005 
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