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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 NameMEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSORS ON PHILLIPS BASE MODELS MMT-7002, MMT-7003
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED, INC.
PMA NumberP980022
Supplement NumberS048
Date Received02/27/2009
Decision Date04/09/2009
Product Code
MDS[ Registered Establishments with MDS ]
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 design changes to the mmt-7002 and mmt-7003 glucose sensors models and a new supplier qualification. The design changes included an increase of the needle tunnel height and base from 0. 034" to 0. 036" and 0. 030" and 0. 031", respectively. These changes were intended to reduce the probability of a user having difficulty with removing the needle after sensor insertion. Further, the connector ledge of the senor base was increased from 0. 007" to 0. 011" to reduce relative rotational motion between the sensor base connector and gst transmitter. Phillips plastics was also qualified as a new supplier for the glucose sensor bases in this supplement. The qualification included modifications including modifications to the needle guard core pin, a manufacturing tooling device. This device is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using a standard home glucose-monitoring devices. This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions.
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