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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 NameVITALITY HE MODEL T180 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND THE CONSULT PROGRAMMER SOFTWARE APPLICAT
Classification Nameprogrammer, pacemaker
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
Regulation Number870.3700
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS053
Date Received03/25/2005
Decision Date05/18/2005
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the vitality he model t180 implantable cardioverter defibrillator (icd) system and the consult programmer software application model 2896 version 1. 0. The device is indicated as follows: guidant icds are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.
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