LUMAX FAMILY OF ICDS/CRT-DS

FDA premarket approval P050023/S001 · decided 2006-12-07

Approval details

PMA number

P050023

Supplement

S001

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

LUMAX FAMILY OF ICDS/CRT-DS

Generic name

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Applicant

Biotronik, Inc.

Date received

2006-09-11

Decision date

2006-12-07

Days to decision

87 days

Decision code

APPR

Product code

MRM

Advisory committee

Cardiovascular

Expedited review

No

Location

Lake Oswego, OR

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 F

510(k) clearances by this applicant