SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED AND VERISENSE SYSTEM AND IBI 1500T9-CP V1.6 CARDIAC

FDA premarket approval P110016/S007 · decided 2013-08-29

Approval details

PMA number

P110016

Supplement

S007

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED AND VERISENSE SYSTEM AND IBI 1500T9-CP V1.6 CARDIAC

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2013-03-07

Decision date

2013-08-29

Days to decision

175 days

Decision code

APPR

Product code

OAD

Advisory committee

Cardiovascular

Expedited review

No

Location

Plymouth, MN

Statement

APPROVAL FOR THE SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED, IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR AND VERISENSE SYSTEM. THIS DEVICE IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMP AND THE1500T9-CP RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETERS ARE INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.

510(k) clearances by this applicant