QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD

FDA premarket approval P030054/S018 · decided 2006-02-15

Approval details

PMA number

P030054

Supplement

S018

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD

Generic name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant

ABBOTT MEDICAL

Date received

2005-11-07

Decision date

2006-02-15

Days to decision

100 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR A MODIFICATION TO THE QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD TO INCREASE THE PEAK-TO-PEAK AMPLITUDE OF THEN DISTAL S-CURVE HEIGHT TO 16 MM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD AND IS INDICATED FOR APPLICATION AS PART OF A ST. JUDE MEDICAL BIVENTRICULAR SYSTEM.

510(k) clearances by this applicant