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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 NameSTELID II BFT/BJF/STELIX BR/STELIX II BRF
Classification Namepermanent defibrillator electrodes
Generic Nameendocardial pacing lead
ApplicantSORIN CRM USA, INC.
PMA NumberP020030
Supplement NumberS009
Date Received01/27/2012
Decision Date02/16/2012
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Clean room layout modifications of saluggia, italy plant.
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