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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 NameINTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD, SECURA ICD,VIRTUOS
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantMEDTRONIC, INC.
PMA NumberP980016
Supplement NumberS407
Date Received04/08/2013
Decision Date05/03/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of an updated acceptance criterion for evaluation of insulator materials used in the manufacture of the subject icds and crt-d devices.
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