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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.
 
DeviceCONTINUOUS GLOCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS071
Date Received04/22/2010
Decision Date10/20/2011
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT00211510
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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