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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.
 
DeviceSPRINT QUATTRO SINGLE COIL DF4, ACTIVE FIXATION LEAD
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP920015
Supplement NumberS091
Date Received05/23/2012
Decision Date07/02/2012
Product Code LWS 
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 A CHANGE TO THE CURRENTLY APPROVED MODEL 6935 SPRINTQUATTRO SECURE S LEAD WHICH IS A SINGLE DEFIBRILLATION COIL IS-1/DF-1 ACTIVE FIXATION LEAD FOR THE CREATION OF A NEW SPRINT QUATTRO SECURE S SINGLE DEFIBRILLATION COIL DF4 ACTIVE FIXATION LEAD, MODEL 6935M.
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