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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 Dispenser
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantMedtimo, Inc.
7625 Golden Triangle Dr.
Suite G
Eden Prairie, MN 55344
PMA NumberP160001
Supplement NumberS027
Date Received10/15/2018
Decision Date01/11/2019
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for software changes relating to battery voltage thresholds and Touch Dispenser screens.
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