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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.
 
DeviceVENTAK FAMILY OF IMPLANTABLE CARIOVERTER DEFIBRILLATOR
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960040
Supplement NumberS094
Date Received12/16/2005
Decision Date01/13/2006
Product Code LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
RECEIVING SPEAKERS WITH POLYMIDE TAPE APPLIED AND THE LEADS TRIMMED TO LENGTH BY THE SPEAKER MANUFACTURER, KNOWLES ELECTRONICS, INC.
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