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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 NameSOF GLUCOSE SENSOR, SOF GLUCOSE SENSOR (MMT-7002, MMT-7003)
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS154
Date Received04/11/2014
Decision Date07/10/2014
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 to lower the purity specification limit for the chromium layer on enlite¿ glucose sensor (mmt-7008) of the minimed 530g system and sof¿ glucose sensor (mmt-7002, mmt-7003) of the paradigm real-time revel system.
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