PMA P980023S008

Device: BELOS VR-T ICD
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S008
Product code: DTA
Decision date: 2002-04-24
Classification: Tester, Pacemaker Electrode Function
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Approval order statement: APPROVAL FOR THE BELOS VR-T ICD HOME MONITORING SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BELOS VR-T ICD WITH PROGRAMMER SOFTWARE (I-K01.0.A/5) AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.

Current openFDA PMA Record#

Device: BELOS VR-T ICD
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S008
Product code: DTA
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Decision date: 2002-04-24
Decision code: APPR
Date received: 2002-04-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE BELOS VR-T ICD HOME MONITORING SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BELOS VR-T ICD WITH PROGRAMMER SOFTWARE (I-K01.0.A/5) AND IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.