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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.
 
DeviceGUIDANT ZOOM PROGRAMMER
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP910077
Supplement NumberS055
Date Received10/31/2005
Decision Date12/20/2005
Product Code LWS 
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 THE HEART FAILURE PARTNER MODEL 2936 MAINTENANCE RELEASE SOFTWARE (SW) VERSION 1.5.
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