RIATA FAMILY OF LEADS

FDA premarket approval P950022/S034 · decided 2007-03-08

Approval details

PMA number

P950022

Supplement

S034

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

RIATA FAMILY OF LEADS

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

ABBOTT MEDICAL

Date received

2006-12-19

Decision date

2007-03-08

Days to decision

79 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE FOLLOWING CHANGES:1)MODIFICATION TO THE CRIMP SLUG WELD TAB 2) MODIFICATION TO THE DISTAL HEADER ASSEMBLY 3) MODIFICATION TO THE PTFE LINER IN THE IS-1 CONNECTOR LEG 4) REMOVAL OF THE PTFE LINERS IN THE TWO DF-1 CONNECTOR LEGS 5) ADDITION OF A DF-1 PLUG ACCESSORY TO THE LEAD PACKAGE 6) ADDITION OF AN EXTRA-SOFT STYLET ACCESSORY TO THE LEAD PACKAGE 7) MINOR MODIFICATIONS TO THE USER MANUAL 8) MODIFIED RADIUS SPECIFICATION FOR THE SPRING STOPPER COMPONENT.

510(k) clearances by this applicant