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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 NameSTELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS
Classification Namepermanent defibrillator electrodes
Generic Nameendocardial pacing lead
ApplicantELA MEDICAL, INC.
PMA NumberP020030
Supplement NumberS001
Date Received07/16/2004
Decision Date11/22/2004
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the introduction of the easyturn deployment mechanism. The device, as modified, will be marketed under the trade name stelix ii easyturn and is indicted for use with an implantable pacemaker. They are intended for permanent pacing and sensing of the atrium.
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