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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 STEROID AND KENTROX SL STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS018
Date Received06/14/2004
Decision Date07/27/2004
Product Code
LWS[ Registered Establishments with LWS ]
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 addition of the steroid collar to the distal end of the lead. The device, as modified, will be marketed under the trade name kentrox sl steroid and kentrox rv steroid and is indicated for use in conjunction with a biotronik icd.
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