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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.
 
DeviceCONCERTO
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 NumberS074
Date Received08/13/2007
Decision Date09/12/2007
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 
CHANGE IN THE VENDOR WHO PERFORMS THE PLASMA CLEANING PROCESS FOR THE PATIENT ALERT FLEX CIRCUIT.
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