RF CONTACTR ABLATION CATHETER

FDA premarket approval P930029/S015 · decided 2001-10-09

Approval details

PMA number

P930029

Supplement

S015

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

RF CONTACTR ABLATION CATHETER

Generic name

Cardiac ablation percutaneous catheter

Applicant

Medtronic, Inc.

Date received

2001-08-06

Decision date

2001-10-09

Days to decision

64 days

Decision code

APPR

Product code

LPB

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR ADDITION OF A SECONDARY DISTAL CURVE FEATURE CAPABLE OF DEFLECTIONS OF UP TO 135 DEGREES AND THE REMOVAL OF THE VARIABLE CURVE REACH FEATURE AND OTHER MINOR DESIGN CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RF CONTACTR ABLATION CATHETER AND IS INDICATED FOR USE WITH A MEDTRONIC RF POWER GENERATOR FOR THE INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA FOR THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA AND

510(k) clearances by this applicant