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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 FAMILY OF TRANSVENOUS DEFIBRILLATION LEADS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP920015
Supplement NumberS016
Date Received08/12/1999
Decision Date09/24/1999
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for adding a caution label to the Medtronic(R) Sprint(TM) Lead Models 6932, 6937, 6942, 6943 and 6945.
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