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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.
 
DeviceCARELINK HOME MONITOR AND CARDIOSIGHT MONITOR
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP890003
Supplement NumberS209
Date Received12/22/2010
Decision Date05/04/2011
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR UPDATES TO MEDTRONIC¿S REVEAL 2090 APPLICATION SOFTWARE MODEL SW007 FOR USE WITH THE MEDTRONIC REVEAL IMPLANTABLE CARDIAC MONITOR (ICM) SYSTEM.
Approval OrderApproval Order
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