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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 AVT AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2812
Classification Nameprogrammer, pacemaker
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
Regulation Number870.3700
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS029
Date Received09/03/2002
Decision Date03/26/2003
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the addition of atrial arrhythmia therapies to the vitality aicd system. The device, as modified, will be marketed under the trade name vitality avt and programmer software application model 2812, and is indicated for use in the following: patients who are icd indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias. 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 <=30% (as defined in the madit ii clinical study appendix).
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