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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.
 
DeviceCAPSURE/CAPSURE Z NOVUS/VITATRON EXCELLENCE SS+/VITATRON IMPULSE II
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 NumberP850089
Supplement NumberS078
Date Received06/08/2011
Decision Date11/18/2011
Product Code
NVY[ Registered Establishments with 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 updates to the sterile packaging assembly process for new and existing sealer equipment.
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