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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 Touch Inflation 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 NumberS007
Date Received11/01/2017
Decision Date09/25/2018
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 Obalon Touch Inflation System (as an alternative to the EzFill Inflation System) to be used with the Obalon Balloon System.
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