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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceObalon Balloon Kit
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantMedtimo, Inc.
7625 Golden Triangle Dr.
Suite G
Eden Prairie, MN 55344
PMA NumberP160001
Supplement NumberS018
Date Received05/16/2018
Decision Date08/01/2018
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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