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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/RELIANCE S STEROID ELUTING EXTENDABLE/RETRACTABLE HELIX ENDOCARDIAL DEFIBRILLATION LEAD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead; accessory stylets
ApplicantGUIDANT CORP.
PMA NumberP910073
Supplement NumberS039
Date Received03/11/2002
Decision Date07/25/2002
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 modified active fixation defibrillation leads. The device, as modified, will be marketed under the trade names endotak reliance and reliance/s leads and is indicated for pacing and rate-sensing and to deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator systems.
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