MEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS

FDA premarket approval P930029/S021 · decided 2004-02-05

Approval details

PMA number

P930029

Supplement

S021

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS

Generic name

Cardiac ablation percutaneous catheter

Applicant

Medtronic, Inc.

Date received

2003-12-10

Decision date

2004-02-05

Days to decision

57 days

Decision code

APPR

Product code

LPB

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR A LINE EXTENSION TO THE COMMERCIALLY AVAILABLE RF ENHANCR CATHETER LINE WITH THE CHANGES LIMITED TO A NEW HANDLE DESIGN AND ASSOCIATED PACKAGING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS AND IS INDICATED FOR USE WITH THE MEDTRONIC RF POWER GENERATOR TO DELIVER RF ENERGY FOR INTRACARDIAC ABLATION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA FOR THE TREATMENT OF AV

510(k) clearances by this applicant