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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.
 
DeviceKAPPA 600/700/800/900 & ENPULSE FAMILIES OF PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS061
Date Received08/21/2006
Decision Date09/19/2006
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIVIRIX MINNEAPOLIS, INC., MILACA, MINNESOTA FOR THE FINAL TESTING, ACTIVATING, LABELING AND PACKAGING OF THE MODEL 2490H CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER.
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