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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.
 
DevicePyloPlus UBT System
Generic NameTest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantArj Medical, Inc.
209 State St. E.
Oldsmar, FL 34677
PMA NumberP170022
Supplement NumberS005
Date Received10/25/2024
Decision Date02/12/2025
Product Code OZA 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the PyloPlus UBT system used with the PyloPlus UBT Hp Pro Analyzer with improved connectivity, user interface, and extended function testing as a standalone device without a PC.
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