INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE

FDA premarket approval P010015/S005 · decided 2003-02-25

Approval details

PMA number

P010015

Supplement

S005

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE

Generic name

Implantable pulse generator, pacemaker (non-CRT)

Applicant

Medtronic, Inc.

Date received

2002-03-04

Decision date

2003-02-25

Days to decision

358 days

Decision code

APPR

Product code

LWP

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE WHICH IS INDICATED AS FOLLOWS: THE INSYNC III MODEL 8042 DEVICE IS INDICATED FOR THE REDUCTION OF SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III OR IV), IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION), AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35%, AND A QRS >=130 MS. RATE ADAPTIVE PACING IS PROVIDED FOR THOSE PATIE

510(k) clearances by this applicant