Medtronic Attain Ability Model 4196 Lead

FDA premarket approval P080006 · Drug eluting permanent left ventricular (lv) pacemaker electrode

PMA numberP080006

Approval

Applicant
Medtronic, Inc.
Received
March 14, 2008
Decision date
April 7, 2009 (APPR)
Supplements
191, latest June 24, 2026
Product code
OJX – Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Official FDA PMA record

Approval order 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.