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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.
 
DeviceCONCENTRO II CRT-D
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 NumberS125
Date Received09/24/2008
Decision Date10/23/2008
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL TO IMPLEMENT A DESIGN CHANGE TO ADD THREE NEW"INTERMEDIATE-FEATURE" MODELS (CONCERTO II MODEL CRT-D D274TRK. VIRTUOSO II ICD MODEL DRD274DRG AND MODEL VR D274VRC) TO THE APPROVED GEN 2 CONSULTA/SECURA/ MAXIMA II FAMILYOF DEVICES (CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK. SECURE VR D224VRC,MAXIMO II DR D284DRG, AND MAXIMO II D284 VRC SUBMITTED UNDER P01003I/S084 ANDP980016/S114, APPROVED MARCH 17, 2008).
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