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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 NameEVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantMEDTRONIC, INC.
PMA NumberP980016
Supplement NumberS410
Date Received04/09/2013
Decision Date05/07/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Seven previously approved manufacture changes for the devices. Those are: 1) update the cmos ic process flow changes at your supplier; 2) update the test software and hardware on the teradyne test platform for m019 and m017 ics; 3) add the high temperature monitor to high power lean line; 4) update the automated assembly equipment controller (aaec); 5) implement a new cleaning process and a curing oven; 6) implement a manufacturing execution system version 7. 9 at various internal suppliers and final device manufacturing locations; and 7) update to the test system software shell.
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