BELOS DR AND BELOS DR-T DUAL-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS

FDA premarket approval P000009/S005 · decided 2002-12-20

Approval details

PMA number

P000009

Supplement

S005

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

BELOS DR AND BELOS DR-T DUAL-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS

Generic name

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Applicant

Biotronik, Inc.

Date received

2002-09-25

Decision date

2002-12-20

Days to decision

86 days

Decision code

APPR

Product code

MRM

Advisory committee

Cardiovascular

Expedited review

No

Location

Lake Oswego, OR

Statement

APPROVAL FOR 1) NEW ADDITIONAL PULSE GENERATORS TO THE BELOS FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND 2) MODIFICATIONS TO THE LEGALLY MARKETED BELOS VR/VR-T ICD SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BELOS DR, DR-T, VR, VR-T ICD SYSTEMS AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYMIAS.

510(k) clearances by this applicant