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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceMINILINK TRANSMITTER (MMT-7703), IPRO DIGITAL RECORDER (MMT-7709) AND IPRO2 RECORDER (MMT-7741)
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
MEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS100
Date Received10/28/2011
Decision Date07/06/2012
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 an increase in battery lead wire length and tolerances, and increase wire stripping tolerances to match with the wire strip tool capabilities affecting the minilink transmitter (mmt-7703), cgms ipro recorder (mmt-7709) and ipro2 recorder (mmt-7741), which are components of the paradigm real-time, paradigm real-time revel, guardian real-time, ipro and ipro2 professional continuous glucose monitoring systems.
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