MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF

FDA premarket approval P980050 · decided 2000-06-14

Approval details

PMA number

P980050

Trade name

MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

Medtronic, Inc.

Date received

1998-12-24

Decision date

2000-06-14

Days to decision

538 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), MODEL 9961 PROGRAMMER APPLICATION SOFTWARE, AND MEDTRONIC(R) SPRINT(TM) MODEL 6943 STEROID ELUTING, SCREW-IN, ATRIAL/VENTRICULAR LEAD. THIS SYSTEM IS INDICATED FOR USE IN ICD PATIENTS EITHER WITH ATRIAL TACHYARRHYTHMIAS OR WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. PATIENTS INDICATED FOR AN ICD ARE THOSE PATIENTS WHO ARE AT RISK OF SUDDEN DEATH DUE TO VENTRICULAR...

510(k) clearances by this applicant