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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.
 
Trade NameMINILINK TRANSMITTER (MMT-7703), IPRO DIGITAL RECORDER (MMT-7709) AND IPRO2 RECORDER (MMT-7741)
Classification Namepump, infusion, insulin, to be used with invasive glucose sensor
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS100
Date Received10/28/2011
Decision Date07/06/2012
Product Code
OYC[ Registered Establishments with OYC ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason design change - minor
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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