Passive Plus DX Endocardial Steroid Eluting, Passive-Fixation Pacing Leads

FDA premarket approval P960030 · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

PMA numberP960030

Approval

Applicant
Abbott Medical
Received
September 9, 1996
Decision date
January 29, 1998 (APPR)
Supplements
81, latest June 26, 2026
Product code
NVN – Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Official FDA PMA record

Approval order statement

Approval for the Passive Plus(R) DX Endocardial, Steroid Eluting, Passive-Fixation Pacing Leads, Models 1342T, 1343K, 1346T, and 1345K. This device is indicated for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (Models 1342T or 1343K) or ventricle (Models 1345K or 1346T).