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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.
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
PMA NumberP890003
Supplement NumberS141
Date Received06/13/2008
Decision Date07/08/2008
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the changes made to the model 2490g medtronic carelink monitor, model 2020a cardiosight reader and model 2491 device data management application (ddma) as follows: 1) updated firmware in the model 2490g carelink monitor and the model 2020a cardiosight reader to provide patient and device data transfer from the reveal xt and reveal dx to the model 2490g carelink monitor. 2) updated firmware in the model 2490g carelink monitor to allow the monitor to facilitate resetting five of the eight notifications of the model 9529 reveal xt used in conjunction with the model 9539 reveal patient assistant. 3) updated firmware in the model 2490g carelink monitor as a preventative measure, to resolve an inconsistency which could potentially cause an invalid carelink transmission to be sent to the carelink network. 4) updated the model 2491 device data management application (ddma) to support the model 9529 reveal xt and the model 9528 reveal dx insertable cardiac monitors.