PMA P910077S041
- Device
- VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S041
- Product code
- LWS
- Decision date
- 2004-02-06
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR CHANGES TO THE INDICATIONS FOR USE AND CLINICAL STUDY SECTION LABELING. THE DEVICES ARE INDICATED FOR: FOR ICDS (VENTAK PRX, MINI, VITALITY, VENTAK AV AND PRIZM): GUIDANT ICDS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. FOR VITALITY AVT:GUIDANT VITALITY AVT IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. THIS DEVICE IS ALSO INTENDED TO PROVIDE ATRIAL ANTITACHYCARDIA PACING AND ATRIAL DEFIBRILLATION TREATMENT IN PATIENTS WHO HAVE OR ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.FOR CRT-DS (CONTAK CD AND RENEWAL):GUIDANT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. GUIDANT CRT-DS ARE ALSO INDICATED FOR REDUCTION OF SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) IN PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS.
Current openFDA PMA Record#
- Device
- VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S041
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2004-02-06
- Decision code
- APPR
- Date received
- 2003-11-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE INDICATIONS FOR USE AND CLINICAL STUDY SECTION LABELING. THE DEVICES ARE INDICATED FOR: FOR ICDS (VENTAK PRX, MINI, VITALITY, VENTAK AV AND PRIZM): GUIDANT ICDS ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. FOR VITALITY AVT:GUIDANT VITALITY AVT IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. THIS DEVICE IS ALSO INTENDED TO PROVIDE ATRIAL ANTITACHYCARDIA PACING AND ATRIAL DEFIBRILLATION TREATMENT IN PATIENTS WHO HAVE OR ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.FOR CRT-DS (CONTAK CD AND RENEWAL):GUIDANT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. GUIDANT CRT-DS ARE ALSO INDICATED FOR REDUCTION OF SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) IN PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF = 120 MS.