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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.
 
Device13 C-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 NumberS004
Date Received06/14/2018
Decision Date07/12/2018
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
Approval Order Statement  
Software and system upgrade to the analytical system used to test solid samples of Cairn’s drug substance. The drug is a component of the 13C-Spirulina gastric emptying breath test (GEBT).
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