PMA P050023S001

Device: LUMAX FAMILY OF ICDS/CRT-DS
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S001
Product code: MRM
Decision date: 2006-12-07
Classification: Defibrillator, Implantable, Dual-chamber
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: APPROVAL FOR THE LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS), MODELS 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T AND 340 HF-T AND PROGRAMMER SOFTWARE VERSION 603.U FOR USE WITH THE LUMAX FAMILY OF ICDS AND BIOTRONIK, INC. PACERS, SINGLE CHAMBER ICDS AND DUAL CHAMBER ICDS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMAX, AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND/OR FOR PROVIDING TREATMENT OF CONGESTIVE HEART FAILURE.

Current openFDA PMA Record#

Device: LUMAX FAMILY OF ICDS/CRT-DS
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S001
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2006-12-07
Decision code: APPR
Date received: 2006-09-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS), MODELS 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T AND 340 HF-T AND PROGRAMMER SOFTWARE VERSION 603.U FOR USE WITH THE LUMAX FAMILY OF ICDS AND BIOTRONIK, INC. PACERS, SINGLE CHAMBER ICDS AND DUAL CHAMBER ICDS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMAX, AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND/OR FOR PROVIDING TREATMENT OF CONGESTIVE HEART FAILURE.