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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 NameENTRUST ICD,INTRINSIC ICD,MARQUIS DR ICD,VR ICD,MAXIMO II ICD,VR ICD,PROTECTA ICD,XT ICD,SECURA ICD,VIRTUOSO ICD
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS363
Date Received06/19/2012
Decision Date01/03/2013
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to update the device labeling with the results from the right ventricular lead integrity alert (rv lia) post-approval study (pas).
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