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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.
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
PMA NumberP980016
Supplement NumberS158
Date Received09/26/2008
Decision Date10/21/2008
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 to implement a design change to use models 2490c medtronic carelink monitor, 2020a cardiosight reader, and 2491 device data management application (ddma) to provide patients and data transfer for the concerto ii model crt-d d274trk, virtuoso ii icd model dr d274drg and model vr d274vrc devices.