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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.
 
DeviceMEDTRONIC SPRINT QUATTRO SECURE MODEL 6947 LEAD
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP920015
Supplement NumberS024
Date Received10/01/2001
Decision Date11/02/2001
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC SPRINT QUATTRO SECURE MODEL 6947 LEAD. THE DEVICE IS INDICATED FOR SINGLE LONG-TERM USE IN THE RIGHT VENTRICLE. THIS LEAD HAS APPLICATION FOR PATIENTS IN WHICH ARRHYTHMIA MANAGEMENT SYSTEMS ARE INDICATED.
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