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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 LEAD
Classification Namepermanent defibrillator electrodes
Applicant MEDTRONIC INC.
PMA NumberP030036
Supplement NumberS009
Date Received08/22/2008
Decision Date02/25/2009
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 the following changes: 1) a change in the manufacturing facility for the drug vial filling process; 2) the addition of a contract laboratory for drug release testing; and 3) a change in a quality control test used to determine a specific attribute of an incoming raw material.
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