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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 Nametranstelephonic follow-up/monitoring system
PMA NumberP910023
Supplement NumberS270
Date Received07/19/2011
Decision Date03/09/2012
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Clinical Trials NCT00916929
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the addition of the corvue thoracic impedance monitoring feature in the unify, fortify and quadra family of devices.
Approval Order Approval Order