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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.
Classification Namepermanent defibrillator electrodes
Generic Nameelectrode, pacemaker, permanent
PMA NumberP830061
Supplement NumberS073
Date Received11/21/2011
Decision Date02/28/2013
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the model 080118 medical adhesive used as an accessory for the capsure, vitatron crystaline, and vitatron excellence ps+ pacemaker leads.