MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974

FDA premarket approval P980050/S015 · decided 2004-04-12

Approval details

PMA number

P980050

Supplement

S015

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

Medtronic, Inc.

Date received

2003-12-12

Decision date

2004-04-12

Days to decision

122 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974. THE DEVICE IS INDICATED AS FOLLOWS: THE MODEL 7276 GEM III AT WITH APP IS INDICATED FOR USE IN ICD PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.

510(k) clearances by this applicant