EZ STEER THERMOCOOL AND

FDA premarket approval P040036/S006 · decided 2008-09-30

Approval details

PMA number

P040036

Supplement

S006

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

EZ STEER THERMOCOOL AND

Generic name

Cardiac ablation percutaneous catheter

Applicant

Biosense Webster, Inc.

Date received

2007-11-23

Decision date

2008-09-30

Days to decision

312 days

Decision code

APPR

Product code

LPB

Advisory committee

Cardiovascular

Expedited review

No

Location

Irvine, CA

Statement

APPROVAL FOR INCORPORATION OF A BIDIRECTIONAL DEFLECTION MECHANISM IN THE NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL CATHETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV CATHETERS AND INDICATED FOR TREATMENT OF TYPE I ATRIAL FLUTTER AND RECURRENT DRUG/DEVICE REFRACTORY SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA.

510(k) clearances by this applicant