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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-SENSOR GLUCOSE SENSORS
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS061
Date Received09/29/2009
Decision Date11/05/2009
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the replacement of the current sof-sensor glucose sensor mmt-7002 and mmt-7003 pouch with a similar one by supplier tolas healthcare. The difference between the two pouches is that the bottom web of the pouch is changed from p/n tpf-0521 to p/n tpf-0521 nc due to the change of the supplier for tolas healthcare.
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