FLEXABILITY ABLATION CATHETER, SENSOR ENABLED

FDA premarket approval P110016/S025 · decided 2017-02-17

Approval details

PMA number

P110016

Supplement

S025

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

FLEXABILITY ABLATION CATHETER, SENSOR ENABLED

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2015-11-05

Decision date

2017-02-17

Days to decision

470 days

Decision code

APPR

Product code

OAD

Advisory committee

Cardiovascular

Expedited review

No

Location

Plymouth, MN

Statement

Approval for the FlexAbility Ablation Catheter, Sensor Enabled is intended for use with the compatible irrigation pump and a compatible RF cardiac ablation generator. The catheter is intended for creating focal endocardial lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of typical atrial flutter.

510(k) clearances by this applicant