|
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 | S006 |
Date Received | 12/23/2016 |
Decision Date | 03/27/2017 |
Product Codes |
MDS OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revisions to patient labeling to include instructions for how users should apply a second Enlite Overtape over the Enlite Sensor. |