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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 (GFR)
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 NumberS003
Date Received09/25/2025
Decision Date11/20/2025
Product Code SDK 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a manufacturing site located at Tjoapack, LLC, 341 JD Yarnell Industrial Parkway, Clinton, TN 37716 for labeling and secondary packaging of device.
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