Attain Starfix Model 4195 Lead

FDA premarket approval P060039 · Drug eluting permanent left ventricular (lv) pacemaker electrode

PMA numberP060039

Approval

Applicant
Medtronic, Inc.
Received
December 27, 2006
Decision date
June 13, 2008 (APPR)
Supplements
116, latest February 10, 2026
Product code
OJX – Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Official FDA PMA record

Approval order statement

APPROVAL FOR THE ATTAIN STARFIX MODEL 4195 LEAD. THE ATTAIN STARFIX MODEL 4195 STEROID ELUTING, TRANSVENOUS LEAD WITH DEPLOYABLE LOBE FIXATION IS INTENDED FOR CHRONIC PACING AND SENSING OF THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED IN CONJUNCTION WITH A COMPATIBLE IMPLANTABLE PULSE GENERATOR OR IMPLANTABLE CARDIAC DEFIBRILLATOR.