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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.
 
DeviceCONSULTA CRT-D, CONCERTO II CRT-D AND MAXIMO II CRT-D
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP010031
Supplement NumberS141
Date Received01/16/2009
Decision Date03/11/2009
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING MINOR DESIGN CHANGES:1) TWO (2) IC DESIGN CHANGES¿ L310 AND L3542) TWO (2) ALTERNATE COMPONENTS¿ DIODE CHANGE (CURRENTLY: XD423 AND PROPOSED: XD445)¿ INSULATED-GATE BIPOLAR TRANSISTOR (IGBT) CHANGE (CURRENTLY: XD405 ANDPROPOSED: XD447)3) PRINTED WIRE BOARD (PWB) CHANGES TO ACCOMMODATE THE ALTERNATE (XD445 DIODE ANDXD447 IGBT) COMPONENTS AND MANUFACTURABILITY IMPROVEMENTS.4) FOUR (4) ICS (L303, L310, L354, AND L409) TO BE TRANSFERRED TO AN ALTERNATIVE ICFABRICATION VENDOR.
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