THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

FDA premarket approval P110016 · decided 2012-01-25

Approval details

PMA number

P110016

Trade name

THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2011-04-15

Decision date

2012-01-25

Days to decision

285 days

Decision code

APPR

Product code

OAD

Advisory committee

Cardiovascular

Expedited review

No

Location

Plymouth, MN

Statement

APPROVAL FOR THE THERAPY COOL PATH DUO ABLATION CATHETER; SAFIRE BLU DUO ABLATION CATHETER; AND IBI 1500T-9 VI.6 CARDIAC ABLATION GENERATOR. THIS DEVICE IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMPAND 1500T9-CP RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETER IS 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