MEDTRONIC MODEL 4806 ATAKR II RF POWER GENERATOR

FDA premarket approval P930029/S013 · decided 2000-11-27

Approval details

PMA number

P930029

Supplement

S013

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC MODEL 4806 ATAKR II RF POWER GENERATOR

Generic name

Cardiac ablation percutaneous catheter

Applicant

Medtronic, Inc.

Date received

2000-02-29

Decision date

2000-11-27

Days to decision

272 days

Decision code

APPR

Product code

LPB

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR A NEW RF GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATAKR II AND IS INDICATED FOR INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA, TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA, AND CREATION OF COMPLETE AV BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.

510(k) clearances by this applicant