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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 Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Nameimplantable cv defibrillator/pacemaker programmer/icd monitoring system
PMA NumberP000009
Supplement NumberS057
Date Received11/25/2013
Decision Date05/04/2014
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Clinical Trials NCT01761162
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for mri-conditional labeling for the entovis sr / sr-t / dr / dr-t pacemakers, and the supporting programmer software version psw 1307. U. When an entovis pacemaker is used in conjunction with setrox s 53/60 or safio 53/60 pacemaker leads it shall be identified as the entovis promri system.
Approval Order Approval Order