|
Device | Guardian™ Connect system |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P160007 |
Supplement Number | S042 |
Date Received | 11/17/2021 |
Decision Date | 12/17/2021 |
Product Code |
MDS |
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 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. |