|
Device | GUARDIAN REAL TIME MONITOR |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S168 |
Date Received | 10/31/2014 |
Decision Date | 01/28/2015 |
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 AN ALTERNATE SUPER CAPACITOR, A COMPONENT USED ON THE INTERFACE BOARDS OF THE GUARDIAN REAL-TIME MONITORS (MODELS CSS7100 AND CSS7100K)WHICH ARE COMPONENTS OF THE GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM. |