Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | CONTINUOUS GLOCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S071 |
Date Received | 04/22/2010 |
Decision Date | 10/20/2011 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR INCORPORATING A USB CONNECTION FOR DATA UPLOAD, CHANGING THE OPERATING TIME BEFORE RECHARGING, CHANGING TO A WEB-BASED SOFTWARE SYSTEM, AND INCORPORATING A DOCKING STATION AND CLEANING PLUG. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADENAME IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM (MMT-7745). |
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