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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
Generic Nameimplant, intragastric for morbid obesity
ApplicantReShape Lifesciences, Inc.
1001 calle amanecer
san clemente, CA 92673
PMA NumberP160001
Date Received01/07/2016
Decision Date09/08/2016
Product Code LTI 
Docket Number 16M-2651
Notice Date 09/14/2016
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT02235870
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S005 S007 S008 S009 S010 S011 S013 S014 
S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S046 S047 
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