TENDRIL ST LEAD MODELS 1888TC AND 1882TC

FDA premarket approval P960013/S018 · decided 2006-06-06

Approval details

PMA number

P960013

Supplement

S018

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

TENDRIL ST LEAD MODELS 1888TC AND 1882TC

Generic name

Pulse generator, permanent, implantable

Applicant

ABBOTT MEDICAL

Date received

2006-04-13

Decision date

2006-06-06

Days to decision

54 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL TO MODIFY THE LEAD INSULATION ON THE TENDRIL ST 1788T/TC AND TENDRIL ST 1782 LEADS, AND TO REDUCE THE OUTER COIL WIRE DIAMETER ON THE TENDRIL ST 1782 LEAD. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES TENDRIL ST LEAD MODEL 1888TC AND TENDRIL ST LEAD MODEL 1882TC. THE TENDRIL ST LEAD MODEL 1888TC IS INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR. THE TENDRIL ST LEAD MODEL 1

510(k) clearances by this applicant