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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 RELIANCE G AND SG ENDOCARDIAL DEFIBRILLATION LEAD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead; accessory stylets
ApplicantGUIDANT CORP.
PMA NumberP910073
Supplement NumberS041
Date Received03/04/2003
Decision Date11/04/2003
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the active and passive fixation endotak family of defibrillation leads and to package the leads with a transvalvular insertion tool for use with a hemostatic introducer. The leads, as modified, will be marketed under the trade name endotak reliance g endocardial defibrillation lead, models 0164, 0165, 0166, 0167, 0174, 0175, 0176, 0177 and endotak reliance sg endocardial defibrillation lead, models 0160, 0161, 0162, 0163.
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