VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
FDA premarket approval P960040/S036 · decided 2004-02-06
Approval details
- PMA number
- P960040
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2003-11-12
- Decision date
- 2004-02-06
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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 O
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