MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE

FDA premarket approval P930029/S018 · decided 2002-12-17

Approval details

PMA number

P930029

Supplement

S018

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE

Generic name

Cardiac ablation percutaneous catheter

Applicant

Medtronic, Inc.

Date received

2002-11-04

Decision date

2002-12-17

Days to decision

43 days

Decision code

APPR

Product code

LPB

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR A CABLE THAT WILL ALLOW A MEDTRONIC RADIO-FREQUENCY ABLATION CATHETER TO FUNCTION AS A DIAGNOSTIC CATHETER BY PROVIDING CONNECTIVITY TO AN EP RECORDING SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE AND IS INDICATED FOR USE DURING DIAGNOSTIC ELECTROPHYSIOLOGIC STUDIES IN CONJUNCTION WITH MEDTRONIC ELECTRODE CATHETERS. THE CABLE IS USED DURING ELECTROPHYSIOLOGY STUDIES TO CONNECT THE ELECTRODE

510(k) clearances by this applicant