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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/SG LEAD MODELS 0180-0187
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead; accessory stylets
ApplicantGUIDANT CORP.
PMA NumberP910073
Supplement NumberS043
Date Received12/08/2003
Decision Date03/02/2004
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of an eptfe coating to the shock coils. The device, as modified, will be marketed under the trade name endotak reliance g/sg lead models and is indicated for providing pacing and rate-sensing and to deliver cardioversion and defibrillation shocks for icd automatic implantable cardioverter defibrillator systems.
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