LUMAX 540 VR-T DX ICD

FDA premarket approval P050023/S029 · decided 2010-04-30

Approval details

PMA number

P050023

Supplement

S029

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

LUMAX 540 VR-T DX ICD

Generic name

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Applicant

Biotronik, Inc.

Date received

2010-03-02

Decision date

2010-04-30

Days to decision

59 days

Decision code

APPR

Product code

MRM

Advisory committee

Cardiovascular

Expedited review

No

Location

Lake Oswego, OR

Statement

APPROVAL FOR INTRODUCTION OF THE LUMAX 540 VR-T DX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), A SINGLE LEAD ICD SYSTEM USED IN CONJUNCTION WITH THE CURRENTLY APPROVED KAINOX A+ ICD LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMAX 540 VR-T DX ICD AND IS INDICATED FOR PROVIDING VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.

510(k) clearances by this applicant