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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 II EASY TURN LEAD MODELS BRF24D, BRF25D, BRF26D
Classification Namepermanent defibrillator electrodes
Generic Nameendocardial pacing lead
ApplicantELA MEDICAL, INC.
PMA NumberP020030
Supplement NumberS003
Date Received05/25/2006
Decision Date07/12/2006
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modifications to the helix mechanism, addition of radiopaque markers, and modifications to the device inspection procedures. The device, as modified, will be marketed under the trade name stelix ii easy turn models brf24d, brf25d, and brf26d and are designed to be used with an implantable pacemaker for pacing and sensing of the heart.
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