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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 NameCAPSURE LEAD/ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO/II ICDS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS304
Date Received06/08/2011
Decision Date07/07/2011
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Upgrade to statistical process control off-the-shelf software that will be used by medtronic energy and component center (mecc).
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