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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.
 
DeviceCONCERTO II/CONSULTA/MAXIMO II
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS260
Date Received06/10/2011
Decision Date07/15/2011
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
SIX CHANGES TO GEN2 HYBRID TESTER: 1) A CHANGE TO THE TEST DECIBEL LIMIT OF THE EGM CMR; 2) A CHANGE TO THE TELEMETRY B VIZSENSE; 3) A CHANGE TO THE R034 STRESS; 4) A CHANGE TO THE JTAG FULL ENERGY DELIVERY PULSE WIDTH; 5) A CHANGE TO LV1 CONTINUITY; AND 6) A CHANGE TO THE CURRENT DRAIN AVVD RF IDD.
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