QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS

FDA premarket approval P030054/S049 · decided 2007-07-25

Approval details

PMA number

P030054

Supplement

S049

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2007-02-05

Decision date

2007-07-25

Days to decision

170 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR DISTAL TIP MODIFICATIONS TO THE QUICKSITE LEAD FAMILY TO REDUCE THE LENGTH OF RIGID SECTIONS AND INCREASE LEAD FLEXIBILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKFLEX MODEL 1156T AND XL MODEL 1158T LEFT VENTRICULAR PACING LEADS. QUICKFLEX LEADS ARE 6 FRENCH, TRANSVENOUS, STEROID ELUTING, BIPOLAR, IS-1 COMPATIBLE, S-SHAPED CURVE, PASSIVE FIXATION LEADS INTENDED FOR PERMANENT SENSING AND PACING OF THE LEFT VENTRICLE WHEN USED WITH A COMPATIBLE ST. JUDE ME

510(k) clearances by this applicant