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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 NameHEART FAILURE PARTNER MODEL 2936 WITH SOFTWARE VERSION 1.1
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator systems
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS048
Date Received11/19/2004
Decision Date03/02/2005
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 the heart failure partner model 2936 with software version 1. 1 which is indicated for interrogating and downloading diagnostic information obtained by guidant's pacemaker and defibrillator cardiac resynchronization therapy (crt-p and crt-d devices.
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