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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 System
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 NumberS005
Date Received09/17/2026
Decision Date10/02/2026
Product Code SDK 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for an additional package integrity test method for routine testing of Lumitrace, and additional verification steps in the monitor manufacturing process.
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