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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 NameENDOTAK ENDURANCE RX ENDOCARDIAL DEFIBRILLATION LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namenonthorocotomy leads for cardioverter
ApplicantGUIDANT CORP.
PMA NumberP910073
Supplement NumberS025
Date Received07/30/1998
Decision Date01/27/1999
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the models 0144, 0145 and 0146 endocardial defibrillation leads. The device, as modified, will be marketed under the trade name endotak(r) endurance (rx(tm)) endocardial defibrillation lead and is indicated for use to provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for ventak aicd automatic implantable cardioverter defibrillator systems.
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