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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 GEBT/13C-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 NumberS002
Date Received07/15/2016
Decision Date01/06/2017
Product Code PGE 
Advisory Committee Clinical Chemistry
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the qualification of additional service providers and the addition of a new test specification for the lyophilized egg (excipient) used in the production of the drug component of the 13C-Spirulina Gastric Emptying Breath Test (GEBT).
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