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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.
 
DeviceSELECTSECURE LEAD
Classification Namepermanent defibrillator electrodes
Generic Namepermanent defibrillator electrodes
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP030036
Supplement NumberS009
Date Received08/22/2008
Decision Date02/25/2009
Product Code
NVY
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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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