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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-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT
Generic NameGastric Emptying Breath Test
ApplicantAdvanced Breath Diagnostics
105 Westpark Dr. Suite 150
Brentwood, TN 37027
PMA NumberP110015
Supplement NumberS010
Date Received05/03/2022
Decision Date06/01/2022
Product Code PGE 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change the quality control testing of the 13C-Spirulina/Egg Mix. The 13C-Spirulina/Egg Mix is a component of the 13C-Spirulina Gastric Emptying Breath Test (GEBT).
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