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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 Z LEADS
Classification Namepermanent defibrillator electrodes
Generic Nameelectrode, pacemaker, permanent
Applicant MEDTRONIC INC.
PMA NumberP850089
Supplement NumberS063
Date Received01/15/2010
Decision Date03/16/2010
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for reformulation of the hotmelt adhesive that is used in medtronic crdm sterile barrier packages.
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