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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.
 
DeviceFINISHING WIRE UNIVERSAL
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantBoston Scientific Corp.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112
PMA NumberP010012
Supplement NumberS005
Date Received11/01/2002
Decision Date12/30/2002
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE EASYTRAK FINISHING WIRE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FINISHING WIRE UNIVERSAL, MODELS 6001 - 6007 AND IS INDICATED FOR USE WITH GUIDANT CORONARY VENOUS LEADS.
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