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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
Classification Namepermanent defibrillator electrodes
Generic Nameelectrode, pacemaker, permanent
Applicant MEDTRONIC INC.
PMA NumberP830061
Supplement NumberS064
Date Received05/05/2011
Decision Date10/04/2012
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a manufacturing site located at medtronic singapore pte. Ltd, in singapore.
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