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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 NameVIRTUOSO,MARQUIS,MAXIMO,INTRINSIC & ENTRUST ICDS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS101
Date Received04/24/2007
Decision Date06/25/2007
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 l325-03 and l325-04 integrated circuit (ic) to minimize the potential for a gate-oxide breakdown within the l325-01, l325-02, and l281-04 ics.
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