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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 NameKAINOX VCS,PROTEGO SD (60/16)(65/16),(65/18)(75/18), PROTEGO TD (65/16)(65/18)(75/18), PROTEGO S (60/65/75)PROTEGO T 65
Classification Namepermanent defibrillator electrodes
Generic Nameimplantable cardioverter defibrillator
PMA NumberP980023
Supplement NumberS065
Date Received03/06/2015
Decision Date07/17/2015
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for implementation of parametric release in place of conventional product release in the sterilization process for permanent pacemaker and defibrillation leads.