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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/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTO/PROTECTO XT/SECURA/VIRTUOSO/VIRTUOSO II/PROTECTA XT DR/PROTECTA DR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS331
Date Received11/21/2011
Decision Date02/28/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 080118 medical adhesive used as an accessory for the entrust, intrinsic, marquis, maximo, maximo ii, protecta, protecta xt, secura, virtuoso, virtuoso ii, protecta xt dr, and protecta dr icds.
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