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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.
 
Device13C-Spirulina Gastric Emptying Breath Test (GEBT)
Generic NameGastric Emptying Breath Test
ApplicantAdvanced Breath Diagnostics
105 Westpark Dr. Suite 150
Brentwood, TN 37027
PMA NumberP110015
Supplement NumberS009
Date Received10/20/2021
Decision Date05/19/2023
Product Code PGE 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT04607304
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of an updated model of Gas Isotope Ratio Mass Spectrometer (GIRMS) for use in analyzing 13C/12C ratios in breath samples as part of your approved 13C-Spirulina Gastric Emptying Breath Test (GEBT)
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