MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM

FDA premarket approval P010015 · decided 2001-08-28

Approval details

PMA number

P010015

Trade name

MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM

Generic name

Implantable pulse generator, pacemaker (non-CRT)

Applicant

Medtronic, Inc.

Date received

2001-03-02

Decision date

2001-08-28

Days to decision

179 days

Decision code

APPR

Product code

LWP

Advisory committee

Cardiovascular

Expedited review

Yes

Location

Mounds View, MN

Statement

APPROVAL FOR THE MEDTRONIC INSYNC BIVENTRICULAR PACING SYSTEM INCLUDING THE MODEL 8040 INSYNC PULSE GENERATOR, THE MODEL 9980 PROGRAMMER SOFTWARE, AND THE ATTAIN LV MODEL 2187 AND ATTAIN CS MODEL 2188 LEADS. THE PULSE GENERATOR AND LEADS ARE INDICATED AS FOLLOWS: 1) THE INSYNC MODEL 8040 PULSE GENERATOR IS INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SECERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL, MEDICAL THER

510(k) clearances by this applicant