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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.
 
Trade NameLATITUDE* PATIENT MANAGEMENT SYSTEM MODELS 6481 AND 6482
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator systems
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS072
Date Received02/08/2007
Decision Date03/09/2007
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the latitude* patient management system models 6481 and 6482 which is used with the prizm, vitality, contak and renewal families of devices. Specifically, the labeling changes include the introduction of errata sheets to address the following issues: 1) yellow alert notification; 2) heart rate display; and 3) weight alert.
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