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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 FAMILY OF ENDOCARDIAL DEFIBRILLATION LEAD MODELS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead; accessory stylets
ApplicantGUIDANT CORP.
PMA NumberP910073
Supplement NumberS027
Date Received07/26/1999
Decision Date09/29/1999
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified df-1 terminal of the endotak(r) series of endocardial defibrillation leads and the model 6952 lead extender, which consists of a shorter terminal pin, a counter bore in the terminal pin, and a modified coil transition.
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