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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.
 
DeviceDDMA SOFTWARE
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP890003
Supplement NumberS251
Date Received06/14/2012
Decision Date09/12/2012
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE USE OF RECENTLY APPROVED SOFTWARE 9995 VERSION 7.4 AND ASSOCIATED DDMA SOFTWARE 2491 WITH RECENTLY APPROVED DEVICE MODELS D264VRM AND D204VRM.
Approval OrderApproval Order
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