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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.
 
DeviceELITE, ELITE II, MINUET, PREVA, PRODIGY, SYNERGYST II, THERA, VITATRON & REVEAL
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS249
Date Received04/04/2012
Decision Date04/25/2012
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
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