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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
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantMEDTRONIC, INC.
PMA NumberP980016
Supplement NumberS411
Date Received04/09/2013
Decision Date04/26/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional assembly line wire bond work cell, and changes to lot release testing and acceptance of gold plated device components.
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