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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.
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP010031
Supplement NumberS260
Date Received06/10/2011
Decision Date07/15/2011
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Six changes to gen2 hybrid tester: 1) a change to the test decibel limit of the egm cmr; 2) a change to the telemetry b vizsense; 3) a change to the r034 stress; 4) a change to the jtag full energy delivery pulse width; 5) a change to lv1 continuity; and 6) a change to the current drain avvd rf idd.