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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 MODEL 6944 LEAD
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP920015
Supplement NumberS017
Date Received06/20/2000
Decision Date12/15/2000
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC(R) SPRINT(TM) QUATTRO(TM) MODEL 6944 LEAD WHICH IS INTENDED FOR SINGLE LONG-TERM USE IN THE RIGHT VENTRICLE. THIS LEAD HAS APPLICATION FOR PATIENTS IN WHICH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS ARE INDICATED.
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