RIATA SERIES 1500 DEFIBRILLATION LEAD SYSTEM

FDA premarket approval P950022/S014 · decided 2002-03-11

Approval details

PMA number

P950022

Supplement

S014

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

RIATA SERIES 1500 DEFIBRILLATION LEAD SYSTEM

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

ABBOTT MEDICAL

Date received

2002-01-31

Decision date

2002-03-11

Days to decision

39 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR NEW DEFIBRILLATION LEAD SYSTEMS AND ACCESSORIES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIAT SERIES 1500 (MODELS 1570, 1571, 1580 AND 1581) DEFIBRILLATION LEAD SYSTEM AND ACCESSORIES (S-65-S, S-65-F, S-65-X, TX-070). THESE DEVICES ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS (REFER TO THE APPLICABLE DEFIBRILLATOR MANUAL FOR SYSTEM INDICATIONS.). THEY PROVIDE PACING AND SENSING AND DELIVER CARDIOVERSION/DEFIBRILLATION THERAPY TO THE HEART.

510(k) clearances by this applicant