RIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 7012

FDA premarket approval P950022/S027 · decided 2006-03-07

Approval details

PMA number

P950022

Supplement

S027

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

RIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 7012

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

ABBOTT MEDICAL

Date received

2006-02-10

Decision date

2006-03-07

Days to decision

25 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR: 1) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001 AND 7002 ACTIVE-FIXATION DEFIBRILLATION LEADS TO CHANGE THE GEOMETRIC PROFILE OF THE INNER COIL AND ADD WHITE PIGMENT TO THE MEDICAL ADHESIVE USED FOR SHOCK COIL BACKFILL. 2) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001, AND 7002 LEADS TO CREATE AN ACTIVE-FIXATION INTEGRATED BIPOLAR LEAD. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RIATA ST MODELS 7010, 7011, AND 7012 AND ARE INDICATED FOR USE WITH COMPATI

510(k) clearances by this applicant