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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 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator,pacemaker programmer;icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS013
Date Received02/19/2003
Decision Date07/29/2003
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study for the device.
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