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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 NamePROTECTS XT VR, PROTECTA VR, SECURA VR MAXIMO II ICD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS280
Date Received02/09/2011
Decision Date05/02/2012
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
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 medtronic protecta¿ xt vr d314vrm, protecta¿ vr d334vrm, secura® vr d204vrm, maximo ii® vr d264vrm icd systems, model 9995 application software v7. 3 and model sw009 application software vl. 0 systems.
Approval Order Approval Order
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