INSYNC SENTRY MODEL 7297 ICD AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.2

FDA premarket approval P010031/S015 · decided 2004-10-26

Approval details

PMA number

P010031

Supplement

S015

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

INSYNC SENTRY MODEL 7297 ICD AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.2

Generic name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2004-06-01

Decision date

2004-10-26

Days to decision

147 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE INSYNC SENTRY MODEL 7297 ICD AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.2. THE DEVICE IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY AND HAVE A LEFT VENTRICULAR