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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.
 
DeviceMODEL VSA02/VSC02 V9.0 PROGRAMMING SOFTWARE FOR THE DIVA, DEMA, AND SELECTION AFM MODEL 902 PULSE GENERATORS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP990001
Supplement NumberS012
Date Received11/22/2002
Decision Date05/20/2003
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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