TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC

FDA premarket approval P960013/S015 · decided 2006-02-07

Approval details

PMA number

P960013

Supplement

S015

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC

Generic name

permanent pacemaker Electrode

Applicant

ABBOTT MEDICAL

Date received

2005-12-08

Decision date

2006-02-07

Days to decision

61 days

Decision code

APPR

Product code

DTB

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES TENDRIL ST MODEL 1788 T, TENDRIL ST MODEL 1788TC, AND TENDRIL ST MODEL 1782TC. THE TENDRIL ST MODEL 1788 LEAD IS DESIGNED FOR PERMANENT SENSING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR. THE TENDRIL ST MODEL 1782 LEAD IS DESIGNED FOR PERMANENT SENSING AND PACING IN THE RIGHT ATRIUM, IN COMBINATION WITH A COMPATIBL

510(k) clearances by this applicant