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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 SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP920015
Supplement NumberS039
Date Received03/03/2008
Decision Date04/29/2008
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A SINGLE-DEFIBRILLATION-COIL VERSION OF THE FDA APPROVED SPRINT QUATTRO MODEL 6947 DUAL-DEFIBRILLATION ?COIL ACTIVE-FIXATION RIGHT VENTRICULAR LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER TE TRADE NAME SPRINT QUATTRO MODEL 6935 LEAD AND IS INTENDED FOR LONG-TERM USE IN THE RIGHT VENTRICLE FOR PATIENTS INDICATED FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
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