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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 NumberS046
Date Received09/01/2004
Decision Date02/10/2005
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
Recalls CDRH Recalls
Approval Order Statement 
Approval for the model 3120 zoom latitude programming system. The model 3120 prm is intended to be used as a complete system to communicate with guidant implantable pulse generators. The software in use controls all communication functions for the pulse generator. For detailed software application instructions, refer to the system guide for the guidant pulse generator being interrogated.