Premarket Approval (PMA)

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 Name: VITALITY AVT AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2812
• Classification Name: programmer, pacemaker
• Generic Name: cardiac resynchronization therapy defibrillator (crt-d) system
• Regulation Number: 870.3700
• Applicant: GUIDANT CORP.
• PMA Number: P960040
• Supplement Number: S029
• Date Received: 09/03/2002
• Decision Date: 03/26/2003
• Product Code: KRG [ Registered Establishments with KRG ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: change design/components/specifications - software
• Expedited Review Granted?: No
• Combination Product: No

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).