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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
Predetermined Change Control Plan AuthorizedNo
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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