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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceMEDTRONIC MINIMED PARADIGM REAL-TIME REVEL PUMP, PARADIGM REAL-TIME PUMP, AND GUARDIAN REAL-TIME MONITOR
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS104
Date Received11/21/2011
Decision Date03/28/2012
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO 1) ADD THE BAYER CONTOUR LINK WIRELESS METER TO THE LIST OF METERS, IN THE LABELING, THAT CAN COMMUNICATE WITH THE PARADIGM REAL-TIME REVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K); 2) ADD THE BAYER CONTOUR NEXT LINK WIRELESS METER TO THE LIST OF METERS , IN THE LABELING, THAT CAN COMMUNICATE WITH THE PARADIGM REAL-TIME REVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K), PARADIGM REAL-TIME SYSTEM (MMT-522, MMT-722, MMT-522K, MMT-722K), AND THE GUARDIAN REAL-TIME CONTINUOUS MONITORING SYSTEM (CSS7100, CSS7100K); AND 3) ENABLE THE BAYER CONTOUR NEXT LINK WIRELESS METER TO FACILITATE TRANSFER OF DATA FROM THE PARADIGM REAL-TIME REVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K), PARADIGM REAL-TIME SYSTEM (MMT-522, MMT -722, MMT -522K, MMT -722K}, AND THE GUARDIAN REAL-TIME CONTINUOUS MONITORING SYSTEM (CSS7100, CSS7100K) TO THE CARELINK THERAPY MANAGEMENT SOFTWARE (MMT-7333, MMT-7335) VIA THE METER USB PORT.
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