PMA P880086S087

Device: ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S087
Product code: DXY
Decision date: 2001-12-21
Classification: Implantable Pacemaker Pulse-generator
Generic name: implantable pacemaker Pulse-generator
Approval order 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.

Current openFDA PMA Record#

Device: ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S087
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2001-12-21
Decision code: APPR
Date received: 2001-11-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.