DURATA FAMILY OF LEADS

FDA premarket approval P950022/S069 · decided 2011-01-24

Approval details

PMA number

P950022

Supplement

S069

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

DURATA FAMILY OF LEADS

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

ABBOTT MEDICAL

Date received

2010-04-22

Decision date

2011-01-24

Days to decision

277 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR 1) DESIGN MODIFICATIONS TO THE SUTURE SLEEVE OF ALL COMMERCIALLY AVAILABLE DURATA LEADS; 2) 7F SUTURE SLEEVE ACCESSORY KIT COMPATIBLE WITH ALL SJM 7F LEADS; 3) REDUCTION IN PVP (FASTPASS) COATING LENGTH FOR ALL DUAL-SHOCK VERSIONS OF COMMERCIALLY AVAILABLE DURATA LEADS; AND 4) DESIGN MODIFICATIONS TO THE IS-1 CONNECTOR CRIMP CONNECTION FOR ALL TRIFURCATED VERSIONS OF THE COMMERCIALLY- AVAILABLE DURATA LEADS.

510(k) clearances by this applicant