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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 2 AICD SYSTEM (MODELS T165, T167, T175, T177), MODEL 2857 APPLICATION SOFTWARE (VERSION 2.2) AND QUICK PROFILE
Classification Nameprogrammer, pacemaker
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
Regulation Number870.3700
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS039
Date Received12/22/2003
Decision Date03/08/2004
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the vitality 2 icd system (models t165, t167, t175, t177), model 2857 application software (version 2. 2), and quick profiles disk (model 2828 version 1. 0). The device is indicated for use in the following: guidant icds are intended to provide therapy for the automated treatment of life-threatening ventricular arrhythmias. Patient populations who are indicated for a guidant icd include: 1) those who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias, or 2) patients who may benefit from prophylactic treatment due to a prior myocardial infarction and an ejection fraction of <= 30%.
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