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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 NameMEDTRONIC PACEMAKER SYSTEMS
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator programming software
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS047
Date Received09/22/2005
Decision Date10/20/2005
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 to activate the capability to remotely update the software in carelink monitor models 2490a/d/e/g/h/j, the model 2030a batterycheck monitor and the model 2020a cardiosight reader with the software versions specified in attachment a for use with the pacemakers and implantable defibrillators as specified in the attachment.
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