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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 NameKENTROX RV-S STEROID AND KENTROX SL-2 STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS017
Date Received04/02/2004
Decision Date09/30/2004
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of a steroid collar to single coil and dual coil lead versions, and modifications to the conductor coil and fixation helix.
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