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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 NameTEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator,pacemaker programmer;icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS005
Date Received06/25/2001
Decision Date10/24/2001
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 modifications to the legally marketed kainox rv and kainox sl lead systems. The device, as modified, will be marketed under the trade name terox rv 65 (model 332 232), terox rv 75 (model 332 231), kainox sl 65/13 (model 124 235), kainox sl 65/16 (model 124 236), kainox sl 65/18 (model 124 237), and is indicated for use with legally marketed biotronik implantable cardioverter defibrillators (icd).
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