THERAPY COOL PATH DUO CATHETER(12 HOLE IRRIGATED),SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED),COOL PATH DUO ABLATION

FDA premarket approval P110016/S010 · decided 2014-03-21

Approval details

PMA number

P110016

Supplement

S010

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

THERAPY COOL PATH DUO CATHETER(12 HOLE IRRIGATED),SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED),COOL PATH DUO ABLATION

Generic name

Cardiac ablation percutaneous catheter

Applicant

ABBOTT MEDICAL

Date received

2013-11-27

Decision date

2014-03-21

Days to decision

114 days

Decision code

APPR

Product code

LPB

Advisory committee

Cardiovascular

Expedited review

No

Location

Plymouth, MN

Statement

APPROVAL FOR MODIFICATION TO THE CURRENTLY MARKETED 1500T9 SERIES CARDIAC ABLATION GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPERE GENERATOR AND IS INDICATED FOR:THE AMPERE GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ABLATION CATHETERS IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT CARDIAC ARRHYTHMIAS.

510(k) clearances by this applicant