Premarket Approval (PMA)

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.

• Device: PyloPlus Urea Breath Test System
• Generic Name: Test, urea adult and pediatric (breath),
• Regulation Number: 866.3110
• Applicant: Arj Medical, Inc.; 209 State St. E.; Oldsmar, FL 34677
• PMA Number: P170022
• Supplement Number: S008
• Date Received: 08/15/2025
• Decision Date: 09/16/2025
• Product Code: OZA
• Advisory Committee: Microbiology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
consolidation of all manufacturing activities to a single location and to increase a manufacturing maximum batch size