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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.
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS020
Date Received06/19/2007
Decision Date01/22/2008
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the cgms ipro system. The cgms ipro system includes the cgms ipro digital recorder, solutions software for cgms ipro, comlink ipro, and cgms ipro wand. The device is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. The information is intended to supplement, not replace, blood glucose information obtained using a standard home glucose-monitoring device. The information collected by the cgms ipro digital recorder may be downloaded, using the comlink ipro, the solutions software for cgms ipro and a personal computer, and reviewed by healthcare professionals. The information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions.