INSYNC III BIVENTRICULAR PACING SYSTEM (MODEL 8041)

FDA premarket approval P010015/S016 · decided 2006-03-07

Approval details

PMA number

P010015

Supplement

S016

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

INSYNC III BIVENTRICULAR PACING SYSTEM (MODEL 8041)

Generic name

Implantable pulse generator, pacemaker (non-CRT)

Applicant

Medtronic, Inc.

Date received

2005-10-06

Decision date

2006-03-07

Days to decision

152 days

Decision code

APPR

Product code

LWP

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR MODIFICATIONS TO THE DEVICE LABELING TO DESCRIBE THE CARE-HF CLINICAL STUDY. MEDTRONIC ALSO REQUESTS A REFORMATTING OF THE INDICATIONS STATEMENT AND THE ADDITION OF A CLINICAL OUTCOMES SECTION TO THE DEVICE LABELING WHICH INCLUDES CLAIMS BASED ON THE PRIMARY ENDPOINT AND TWO SECONDARY ENDPOINTS IN THE CARE-HF STUDY. THE MEDTRONIC INSYNC III MODEL 8042 IS INDICATED FOR NYHA FUNCTIONAL CLASS III AND IV PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY (AS DEFINED

510(k) clearances by this applicant