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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.
 
DeviceQUICKSITE FAMILY OF LEADS-MODELS 1056K, 1056T AND 1058T & QUICKFLEX FAMILY OF LEADS-MODELS 1156T AND 1158T
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS083
Date Received03/10/2008
Decision Date04/23/2008
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE STYLETS, PACKAGING AND LABELING FOR THE QUICKSITE AND QUICKFLEX LEAD FAMILIES.
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