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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 NameICD FAMILY OF DEVICES & FORTIFY FAMILY OF DEVICES
Classification Namepulse generator, permanent, implantable
Generic Nametranstelephonic follow-up/monitoring system
ApplicantST. JUDE MEDICAL
PMA NumberP910023
Supplement NumberS295
Date Received05/25/2012
Decision Date08/09/2012
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval of model mn5000 version 6. 1 software to be used with the merlin. Net systen and for the model ex2000 version 6. 1 software to be used on merlin at home devices.
Approval Order Approval Order
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