RF ENHANCER 7 FRENCH, 5 MM ABLATION CATHETER

FDA premarket approval P930029/S017 · decided 2002-05-31

Approval details

PMA number

P930029

Supplement

S017

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

RF ENHANCER 7 FRENCH, 5 MM ABLATION CATHETER

Generic name

Cardiac ablation percutaneous catheter

Applicant

Medtronic, Inc.

Date received

2002-03-18

Decision date

2002-05-31

Days to decision

74 days

Decision code

APPR

Product code

LPB

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR ABLATION CATHETERS WHICH FEATURE DESIGN CHANGES TO THE PERFORMER CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKED UNDER THE TRADE NAME RF ENHANCER 7FRENCH, 5 MM ABLATION CATHETER 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 NODAL RE-ENTRANT TACHYCARDIA AND FOR CREATION OF COMPLETE AV BLOCK IN PATIENTS WITH A DIFF

510(k) clearances by this applicant