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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.
 
DeviceMediBeacon® Transdermal GFR Measurement System (TGFR)
Generic NameTransdermal test for Assessment of Glomerular Filtration Rate
ApplicantMedibeacon, Inc.
425 N. New Ballas Rd.
Suite 100
St. Louis, MO 63141
PMA NumberP230019
Supplement NumberS001
Date Received03/04/2025
Decision Date12/15/2025
Product Code SDK 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT05777174
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
for the addition of the MediBeacon Reusable Sensor to the MediBeacon® Transdermal GFR System and the extension of the Lumitrace component shelf life from 1 year to 2 years.
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