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Device | iPro2 Continuous Glucose Monitoring (CGM) System |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S200 |
Date Received | 06/22/2017 |
Decision Date | 08/11/2017 |
Product Codes |
MDS OYC |
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 design changes to the battery component of the GSR2 recorder. The GSR2 recorder is a component of the iPro2 Continuous Glucose Monitoring System and the iPro2 Professional Continuous Glucose Monitoring System. |