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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 LEAD
Classification Namepermanent defibrillator electrodes
Generic Nameelectrode, pacemaker, permanent
ApplicantMEDTRONIC, INC.
PMA NumberP830061
Supplement NumberS106
Date Received01/22/2014
Decision Date02/04/2014
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 Yes
Approval Order Statement 
Alternate manufacturing facility of existing supplier, and utilization of supplier quality management (sqm) as the incoming inspection control for thermoformed blister trays.
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