BI-DIRECTIONAL THERAPY COOL PATH DUO IRRIGATED ABLATION CATHETERS

FDA premarket approval P110016/S006 · decided 2013-04-18

Approval details

PMA number

P110016

Supplement

S006

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

BI-DIRECTIONAL THERAPY COOL PATH DUO IRRIGATED ABLATION CATHETERS

Generic name

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Applicant

ABBOTT MEDICAL

Date received

2013-01-24

Decision date

2013-04-18

Days to decision

84 days

Decision code

APPR

Product code

OAD

Advisory committee

Cardiovascular

Expedited review

No

Location

Plymouth, MN

Statement

APROVAL FOR A MODIFIED CATHETER USING A TIP ELECTRODE WITH 12 IRRIGATION HOLES FROM THE CURRENTLY APPROVED SAFIRE BLU DUO BI-DIRECTIONAL ABLATION CATHETER WITH THE SHAFT AND HANDLE OF THE CURRENTLY APPROVED THERAPY COOL PATH BI-DIRECTIONAL ABLATION CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERAPY COOL PATH DUO BI-DIRECTIONAL CATHETER AND IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMP AND 1500T9 CP RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. T

510(k) clearances by this applicant