PMA P830045S080

Device: ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Applicant: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S080
Product code: KRG
Decision date: 2001-12-21
Classification: Cardiovascular
Generic name: Programmer, pacemaker
Approval order statement: APPROVAL FOR THE ATLAS 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: St. Jude Medical, Inc.
PMA number: P830045
Supplement: S080
Product code: KRG
Generic name: Programmer, pacemaker
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 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.