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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 NumberS237
Date Received04/22/2010
Decision Date10/19/2010
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for modifications to the medtronic enrhythm pulse generators and entrust (d153atg, d153vrc, d154atg, d154vrc, d154drg) programmer application software model 9987 (version 7. 2), model 2491 device data management application (ddma) (part of model 2490g carelink monitor system), firmware, and the post sterilization manufacturing test software.
Approval Order Approval Order