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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 NameGEM III AT ICD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Applicant MEDTRONIC INC.
PMA NumberP980050
Supplement NumberS035
Date Received07/28/2008
Decision Date11/21/2008
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for component, design, manufacturing process, and labeling updates to the medtronic 2090 carelink programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (lcd), a local area network (lan) on the micro-processing unit (mpu), new hard drives, updates to the link electronics module (lem), and other minor changes to address obsolete components.
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