Tendril DX Model 1388T & 1388K Endocardial Pacing Leads

FDA premarket approval P960013 · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

PMA numberP960013

Approval

Applicant
Abbott Medical
Received
May 10, 1996
Decision date
June 20, 1997 (APPR)
Supplements
129, 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 TENDRIL(R) DX MODELS 388T/K ENDOCARDIAL, STEROID ELUTING, SCREW-IN PACING LEADS AND VENTRITEX ASSURE(TM) AFS MODELS 7010T/K ENDOCARDIAL, STERIOID ELUTING SCREW-IN PACING LEADS. THESE DEVICES ARE INDICATED FOR USE IN COMBINATION IWTH A COMPATIBLE PULSE GENERATOR TO PROVIDE PERMANENT PACING AND SENSING IN EITHER THE ATRIUM OR VENTRICLE.