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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePREVA ST DR MODEL 7078 AND THE PREVA D MODEL 7068 IMPLANTABLE PULSE GENERATORS, AND MODEL 9559 SOFTWARE
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS048
Date Received10/22/1996
Decision Date11/19/1996
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
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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