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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSYNCRA/CONSULTA CRT-P
Classification Namepulse generator, permanent, implantable
Applicant MEDTRONIC INC.
PMA NumberP010015
Supplement NumberS125
Date Received05/19/2011
Decision Date07/01/2011
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of modification to the 2490g software requirements specification to add the crt-p device model numbers to the auto-id list for the model 2020a cardiosight reader.
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