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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 NameSELECTSECURE 3830
Classification Namepermanent defibrillator electrodes
Generic Namepacing lead
Applicant MEDTRONIC INC.
PMA NumberP030036
Supplement NumberS003
Date Received02/26/2007
Decision Date10/21/2008
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a change to the 1 cc syringe used to manually measure application with a manually operated automated dispenser and to modify the dimensions of the filling tube to prevent over-fill of the precisely measured steroid solution within the filling tube.
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