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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(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead; accessory stylets
ApplicantGUIDANT CORP.
PMA NumberP910073
Supplement NumberS030
Date Received01/11/2000
Decision Date02/23/2000
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
All previously marketed intermedics stylets to be marketed under new guidant model numbers 6032-6066,6765-6770,6826,6828,6963,6964,6971,6972,6983,and 6985. Also approved an alternate stylet kit package insert.
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