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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 NameVITATRON CRYSTALINE/VITATRON EXCELLENCE +/VITATRON EXCELLENCE PS+/CAPSURE SP/CAPSURE SENSE/CAPSURE SP NOVUS/CAPSURE LEAD
Classification Namepermanent defibrillator electrodes
Generic Nameelectrode, pacemaker, permanent
Applicant MEDTRONIC INC.
PMA NumberP830061
Supplement NumberS058
Date Received10/26/2010
Decision Date11/23/2010
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of an updated version of the statistical process control (spc) software system across multiple manufacturing locations and vertically integrated suppliers.
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