TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS

FDA premarket approval P960013 · decided 1997-06-20

Approval details

PMA number

P960013

Trade name

TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS

Generic name

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Applicant

ABBOTT MEDICAL

Date received

1996-05-10

Decision date

1997-06-20

Days to decision

406 days

Decision code

APPR

Product code

NVN

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

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.

510(k) clearances by this applicant