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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSORS ON PHILLIPS BASE MODELS MMT-7002, MMT-7003
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS048
Date Received02/27/2009
Decision Date04/09/2009
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES TO THE MMT-7002 AND MMT-7003 GLUCOSE SENSORS MODELS AND A NEW SUPPLIER QUALIFICATION. THE DESIGN CHANGESINCLUDED AN INCREASE OF THE NEEDLE TUNNEL HEIGHT AND BASE FROM 0.034" TO 0.036" AND0.030" 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 RELATIVEROTATIONAL 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 THENEEDLE GUARD CORE PIN, A MANUFACTURING TOOLING DEVICE. THIS DEVICE IS INTENDED TOCONTINUOUSLY RECORD INTERSTITIAL GLUCOSE LEVELS IN PERSONS WITH DIABETES MELLITUS. THISINFORMATION 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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