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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 SENSE BIPOLAR LEAD 4074, CAPSURE SENSE BIPOLAR LEAD 4574
Classification Namepermanent defibrillator electrodes
Generic Nameelectrode, pacemaker, permanent
ApplicantMEDTRONIC, INC.
PMA NumberP830061
Supplement NumberS109
Date Received06/19/2014
Decision Date07/16/2014
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of an equivalent sterilizer and aerator.
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