ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
FDA premarket approval P880086/S087 · decided 2001-12-21
Approval details
- PMA number
- P880086
- Supplement
- S087
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2001-11-29
- Decision date
- 2001-12-21
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE ATLAS (TM) DR/VR (MODELS V-240 AND V-199) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTWARE VERSION 3.1. THESE DEVICES ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
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