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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMARQUIS, MAXIMO, INSYNC, ENTRUST, AND INTRINSIC FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP010031
Supplement NumberS036
Date Received02/09/2006
Decision Date03/09/2006
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADDITION OF AN IN-PROCESS QUALITY ASSURANCE (QA) TEST TO THE FINAL FUNCTIONAL TESTING.
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