FLEXABILITY ABLATION CATHETER

FDA premarket approval P110016/S013 · decided 2015-01-23

Approval details

PMA number

P110016

Supplement

S013

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

FLEXABILITY ABLATION CATHETER

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2014-06-19

Decision date

2015-01-23

Days to decision

218 days

Decision code

APPR

Product code

OAD

Advisory committee

Cardiovascular

Expedited review

No

Location

Plymouth, MN

Statement

APPROVAL FOR THE FLEXABILITY ABLATION CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLEXABILITY ABLATION CATHETERAND IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMP AND A COMPATIBLE RF CARDIACABLATION GENERATOR. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIACABLATION PROCEDURES (MAPPING STIMULATION, AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.

510(k) clearances by this applicant