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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 Nameimplantable cardioverter defibrillator systems
PMA NumberP910077
Supplement NumberS083
Date Received12/11/2007
Decision Date01/30/2008
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the latitude communicator software (model 6482) version 2. 1 and related system software (model 6488) that contains regulated application server (ras) software version 2. 40 as well as associated labeling and operator manual updates. The software modifications are intended to support new device models (livian), make minor software corrections, and improve ease of use with the latitude system.