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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 NameCONCERTO
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS088
Date Received12/10/2007
Decision Date01/03/2008
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor design changes that add alternate components, diodes (xd433, xd445) and capacitor (avx kyocera x5r), to the approved device components for use on the hybrid as well as minor associated modifications to the substrate. The design modifications are intended to increase supply line robustness, reduce component costs, and improve incoming component quality.
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