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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 NameCAPSURE, CAPSURE Z NOVUS & VITATRON EXCELLENCE SS
Classification Namepermanent defibrillator electrodes
Generic Nameelectrode, pacemaker, permanent
Applicant MEDTRONIC INC.
PMA NumberP850089
Supplement NumberS080
Date Received06/27/2011
Decision Date07/27/2011
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of second supplier of silicone tubing.
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