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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 NameADHESIVE, CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELENCE PS+LEAD
Classification Namepermanent defibrillator electrodes
Generic Nameelectrode, pacemaker, permanent
ApplicantMEDTRONIC, INC.
PMA NumberP830061
Supplement NumberS093
Date Received05/17/2013
Decision Date07/23/2013
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an increase in the storage shelf life of the tyvek lid component, which includes the adhesive coating, used in the medtronic cardiac rhythm disease management products from 18 months to 48 months.
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