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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 NameSELECTED FAMILIES OF ICD'S, ENTRUST FAMILY,INTRINSIC FAMILY,ONYX, MAXIMO FAMILY, MARQUIS FAMILY,GEM III FAMILY,GEM II FA
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS072
Date Received04/10/2006
Decision Date05/08/2006
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the support for the insync iii marquis to the 2490g carelink monitor and the 2491 device data management application (ddma) software, and the updates to the firmware used in the 2490g carelink monitor and updates to the 2491 ddma software.
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