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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 NumberS049
Date Received03/18/2011
Decision Date06/16/2011
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling id number on the tray.
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