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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.
 
DevicePREVA ST DR MODEL 7078 AND THE PREVA D MODEL 7068 IMPLANTABLE PULSE GENERATORS, AND MODEL 9559 SOFTWARE
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS048
Date Received10/22/1996
Decision Date11/19/1996
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO COMMERCIALLY DISTRIBUTE THE MEDTRONIC PREVA ST DR MODEL 7078 AND PREVA D MODEL 7068 PULSE GENERATORS; AND THE MODEL 9959 SOFTWARE
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