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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 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
Supplement NumberS003
Date Received11/16/2016
Decision Date04/25/2017
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the additional of a plant-based capsule material option.
Post-Approval StudyShow Report Schedule and Study Progress
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