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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 NameVARIOUS FAMILIES OF PACEMAKERS, CARELINK MONITOR, CARDIO SIGHT READER
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS116
Date Received02/28/2007
Decision Date05/04/2007
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 updates to the carelink v1. 1 device data management application to (1) provide support for concerto with atrial therapies; (2) allow transmission of an ?alert? signal for at/af burden and fast v response observations if there is an associated alert; (3) output the type of episode log for invalid episodes so carelink can properly display invalid episodes as arrhythmia episodes or ventricular sensing episodes; and (4) correct a problem where the cardiac compass ?ventricular rate during at/af? graph does not always print the mean ventricular rate.
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