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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 NameLINOX SMART SD60/16; SD 65/16; 65/18, 75/18; S60, S65, S75, S DX 65/15, 65/17, T65, TD 65/16, 65/18, VOLTA TA ICR60,65,7
Classification Namepermanent defibrillator electrodes
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS064
Date Received02/04/2015
Decision Date02/20/2015
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Replace finished steroid eluting leads with lead dummies for the particulate matter testing.
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