April 8, 2011

FDA PMA 2011

FDA released the January and February PMA Approvals. Yeah I know. It is right up there with Steve Martin finding his name in the phone book, exciting just doesn't explain it, but here goes:

P980022/S090
1/7/11
Real-Time Medtronic Minimed Continuous Glucose Monitoring System Medtronic, Inc.
Northridge, CA 91325 Approval for a modification to the design specification of the lumen tubing used in the manufacturing process of the glucose sensor to allow for less dimensional variation in the tubing supplied by the tubing vendor.

P980022/S092
1/31/11
Real-Time Medtronic Minimed Continuous Glucose Monitoring System Medtronic, Inc.
Northridge, CA
91325 Approval for a software change to the CareLink® Personal Therapy Management Software for Diabetes, MMT-7333, from version 5.3A to 5.4A.

P050020/S022
1/14/11
180-Day Freestyle Navigator Continuous Glucose Monitoring System Abbott Diabetes Care
Alameda, CA
94502 Approval for changes to the outgoing Quality Control (QC) solution testing.

P980022/S091
1/12/11 Continuous Glucose Monitoring System Medtronic, Inc. Northridge, CA 91325 Minor manufacturing changes to the Sof-Sensor™ Glucose Sensor MMT-7002.


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