MediBeacon® Transdermal GFR Measurement System (TGFR)
FDA premarket approval P230019/S001 · decided 2025-12-15
Approval details
- PMA number
- P230019
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MediBeacon® Transdermal GFR Measurement System (TGFR)
- Generic name
- Transdermal test for Assessment of Glomerular Filtration Rate
- Applicant
- Medibeacon, Inc.
- Date received
- 2025-03-04
- Decision date
- 2025-12-15
- Days to decision
- 286 days
- Decision code
- APPR
- Product code
- SDK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- St. Louis, MO
- 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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