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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.
 
DeviceCGMS IPRO CONTINUOUS GLOCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
MEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS047
Date Received02/09/2009
Decision Date04/06/2009
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MODIFICATION TO THE SOLUTIONS SOFTWARE FOR THE CGMS IPRO CONTINUOUS GLUCOSE RECORDER (MMT-7319) TO ADD AN AUTO DETECT FEATURE TO ALLOW THE SOFTWARE TO AUTOMATICALLY RECOGNIZE THE COMPUTER¿S ACTIVE PORTS AND TO CORRECT PREVIOUSLY IDENTIFIED ANOMALIES.
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