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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/SUREFIX/VITATRON CRYSTALLINE ACTFIX & PIROUET S+
Classification Namepermanent defibrillator electrodes
Generic Namepacing lead
Applicant MEDTRONIC INC.
PMA NumberP930039
Supplement NumberS056
Date Received06/08/2011
Decision Date11/18/2011
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
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