|
Device | iPro2 CGM System with Enlite Glucose Sensor |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150029 |
Supplement Number | S036 |
Date Received | 01/27/2021 |
Decision Date | 02/25/2021 |
Product Codes |
MDS OZO |
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 an update to product labeling to warn against a new interference by Hydroxyurea to the continuous glucose monitoring (CGM) component of the system. |