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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 STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead; accessory stylets
ApplicantGUIDANT CORP.
PMA NumberP910073
Supplement NumberS042
Date Received05/05/2003
Decision Date06/24/2003
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for 70-cm lead lengths for the endotak reliance steroid eluting endocardial defibrillation lead (models 0143 and 0153).
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