PMA P980023S004

Device: BELOS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S004
Product code: DTA
Decision date: 2001-07-12
Classification: Tester, Pacemaker Electrode Function
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Approval order statement: APPROVAL FOR A NEW ICD SYSTEM THAT INCLUDES THE FOLLOWING: BELOS VR ICD (MODEL 330 444), BELOS TEST HOUSING (MODEL 331 116), AND BELOS VR PHYLAX XM/MYCROPHYLAX/PHYLAX 06/TMS 1000 APPLICATION SOFTWARE 1-K01.0.A (MODEL 338 045). THE DEVICE, AS MODIFIED IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.

Current openFDA PMA Record#

Device: BELOS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S004
Product code: DTA
Generic name: TESTER, PACEMAKER ELECTRODE FUNCTION
Decision date: 2001-07-12
Decision code: APPR
Date received: 2001-04-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW ICD SYSTEM THAT INCLUDES THE FOLLOWING: BELOS VR ICD (MODEL 330 444), BELOS TEST HOUSING (MODEL 331 116), AND BELOS VR PHYLAX XM/MYCROPHYLAX/PHYLAX 06/TMS 1000 APPLICATION SOFTWARE 1-K01.0.A (MODEL 338 045). THE DEVICE, AS MODIFIED IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.