|
Device | iPro2 CGM System with Enlite Sensor |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150029 |
Supplement Number | S016 |
Date Received | 02/09/2018 |
Decision Date | 03/07/2018 |
Product Codes |
MDS OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a minor design change to the introducer needle component of the Guardian Sensor (3) and the Enlite Sensor and the addition of an alternate needle supplier. |