|
Device | Paradigm™ Real-Time Revel™ System |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150019 |
Supplement Number | S064 |
Date Received | 11/17/2021 |
Decision Date | 12/17/2021 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a labeling update to provide additional clarity on an existing warning for acetaminophen interference to the continuous glucose monitoring (CGM) component of the system. |