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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceENDOTAK(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP910073
Supplement NumberS030
Date Received01/11/2000
Decision Date02/23/2000
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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