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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 NumberS074
Date Received02/23/2007
Decision Date06/15/2007
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 modifications to the model 6482 rt communicator for use on the latitude patient management system. The modifications include a software upgrade (version 1. 7. 0) and changes to the hardware to increase rf transmit power.