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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.
 
DeviceMEDTRONIC MODEL 2090 BURBOT AND SPLAKE PROGRAMMERS
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS120
Date Received05/14/2007
Decision Date06/07/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE HARD DISK DRIVE (HDD) USED ON MEDTRONIC MODEL 2090 ?BURBOT? THAT ALSO INCLUDES A MINOR DESIGN CHANGE AND AN ALTERNATE FLOPPY DISC DRIVE (FDD) USED ON BOTH MEDTRONIC MODEL 2090 ?SPLAKE? AND ?BURBOT? CARELINK PROGRAMMERS.
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