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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
105 westpark dr.
suite 150
brentwood, TN 37027
PMA NumberP110015
Supplement NumberS007
Date Received02/23/2021
Decision Date03/16/2021
Product Code PGE 
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Changes to the quality control process used during the manufacture of the 13C-Spirulina substrate. The substrate is a component of the GEBT.