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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 NumberS008
Date Received03/16/2021
Decision Date08/10/2021
Product Code PGE 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to labeling that will facilitate telehealth administration of the device.
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