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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 LEAD
Classification Namepermanent defibrillator electrodes
Generic Nameelectrode, pacemaker, permanent
Applicant MEDTRONIC INC.
PMA NumberP830061
Supplement NumberS086
Date Received03/20/2013
Decision Date02/18/2014
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
Approval for removal of the dexamethasone sodium phosphate (dsp) coating from the lead tip and the manufacturing site change for the monolithic controlled release device (mcrd) for the capsure sense family of leads.
Approval Order Approval Order
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