THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER

FDA premarket approval P110016/S003 · decided 2013-07-30

Approval details

PMA number

P110016

Supplement

S003

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2012-06-25

Decision date

2013-07-30

Days to decision

400 days

Decision code

APPR

Product code

OAD

Advisory committee

Cardiovascular

Expedited review

No

Location

Plymouth, MN

Statement

APPROVAL FOR ADDING A MEDIGUIDE TECHNOLOGY PASSIVE SENSOR INTO THE TIP OF THE DEVICE FOR THE PURPOSES OF AIDING NAVIGATION AND CHANGING THE COOL PATH DUO UNI-DIRECTIONAL (UNI-D) HANDLE TO A COOL PATH DUO BI-DIRECTIONAL (BI-D) HANDLE. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES COOL PATH DUO ABLATION CATHETER, MEDIGUIDE ENABLED AND SAFIRE DUO ABLATION CATHETER, MEDIGUIDE ENABLED AND ARE INDICATED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, ST

510(k) clearances by this applicant