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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 NameMODEL VSA02/VSC02 V9.0 PROGRAMMING SOFTWARE FOR THE DIVA, DEMA, AND SELECTION AFM MODEL 902 PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator programming software
Regulation Number870.3610
ApplicantVITATRON, INC.
PMA NumberP990001
Supplement NumberS012
Date Received11/22/2002
Decision Date05/20/2003
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model vsa02/vsc02 v9. 0 programming software for the diva, dema, and selection afm model 902 pulse generators including the upgrade of the selection afm model 902 to include ventricular rate stabilization.
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