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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.

Premarket Approval (PMA) Database

Trade NameCONTAK AND RENEWAL FAMILIES
Classification Namepulse-generator, dual chamber, implantable
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS126
Date Received05/05/2006
Decision Date08/08/2006
Product Code
LWP [ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type normal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Approval Order Statement  Latitude patient management system model 6481 inductive communicator & software v1. 2. 0 and regulated application server (ras) v2. 0. 3.

Database Updated 02/06/2009

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