THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER

FDA premarket approval P990071/S013 · decided 2011-12-21

Approval details

PMA number

P990071

Supplement

S013

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER

Generic name

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Applicant

Biosense Webster, Inc.

Date received

2011-06-20

Decision date

2011-12-21

Days to decision

184 days

Decision code

APPR

Product code

OAE

Advisory committee

Cardiovascular

Expedited review

No

Location

Irvine, CA

Statement

APPROVAL FOR THE FOLLOWING MODIFICATIONS: 1) REDUCED RECOMMENDED SALINE FLOW RATE (REDUCE BY ~50%; 2) INCREASE IN NUMBER OF IRRIGATION HOLES (FROM 6 TO 56); 3) DECREASE IN SIZE OF IRRIGATION HOLES (FROM 0.016¿ TO 0.0035¿ DIAMETER); AND 4) MODIFIED TIP ELECTRODE MATERIAL (FROM 90% PLATINUM/10% IRIDIUM TO 80% PALLADIUM/20% PLATINUM).THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES UNI-DIRECTIONAL CARTO XP THERMOCOOL SF NAV CATHETER, UNI-DIRECTIONAL CARTO 3 THERMOCOOL SF NAV CATHETER,

510(k) clearances by this applicant