MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD

FDA premarket approval P080006 · decided 2009-04-07

Approval details

PMA number

P080006

Trade name

MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD

Generic name

Drug eluting permanent left ventricular (lv) pacemaker electrode

Applicant

Medtronic, Inc.

Date received

2008-03-14

Decision date

2009-04-07

Days to decision

389 days

Decision code

APPR

Product code

OJX

Advisory committee

Cardiovascular

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL FOR THE ATTAIN ABILITY MODEL 4196 LEAD. THE ATTAIN ABILITY MODEL 4196 STEROID ELUTING, DUAL ELECTRODE, IS-1TRANSVENOUS LEAD IS INDICATED FOR CHRONIC PACING AND SENSING IN THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED IN CONJUNCTION WITH A COMPATIBLE MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY (CRT) SYSTEM. EXTENDED BIPOLAR PACING IS AVAILABLE USING THIS LEAD IN COMBINATION WITH A COMPATIBLE CRT-D SYSTEM AND RV DEFIBRILLATION LEAD OR WITH A COMPATIBLE CRT-P SYSTEM AND RV PACING LEAD

510(k) clearances by this applicant