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.
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Premarket Approval (PMA) Database
Trade Name | CONCERTO ICD |
Classification Name | defibrillator, automatic implantable cardioverter, with cardiac resynchronization |
Generic Name | cardiac resynchronization therapy |
Applicant | MEDTRONIC VASCULAR |
PMA Number | P010031 |
Supplement Number | S062 |
Date Received | 01/16/2007 |
Decision Date | 03/15/2007 |
Product Code |
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Advisory Committee |
Cardiovascular
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Supplement Type |
real-time process |
Supplement Reason | design change - minor |
Expedited Review Granted? |
No
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Approval Order Statement
Approval for minor design changes to the battery connector module for entrust 35j, concerto, and virtuoso icds.
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