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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 NameSECURA DR/VR, VIRTUOSO II DR/VR AND MAXIMO II DR/VR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS175
Date Received01/16/2009
Decision Date03/11/2009
Product Code
LWS[ Registered Establishments with LWS ]
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 the following minor design changes: 1) two (2) ic design changes ¿ l310 and l354 2) two (2) alternate components ¿ diode change (currently: xd423 and proposed: xd445) ¿ insulated-gate bipolar transistor (igbt) change (currently: xd405 and proposed: xd447) 3) printed wire board (pwb) changes to accommodate the alternate (xd445 diode and xd447 igbt) components and manufacturability improvements. 4) four (4) ics (l303, l310, l354, and l409) to be transferred to an alternative ic fabrication vendor.
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