Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter

FDA premarket approval P150005/S014 · decided 2017-12-21

Approval details

PMA number

P150005

Supplement

S014

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter

Generic name

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Applicant

Boston Scientific Corp

Date received

2017-02-22

Decision date

2017-12-21

Days to decision

302 days

Decision code

APPR

Product code

OAE

Advisory committee

Cardiovascular

Expedited review

No

Location

St Paul, MN

Statement

Approval for the Blazer and IntellaNav Open-Irrigated Ablation Catheters. The Blazer and IntellaNav Open-Irrigated Ablation Catheters, when used with a compatible Radiofrequency Controller and Irrigation Pump, are indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, radiofrequency ablation of sustain or recurrent Type 1 Atrial Flutter in patients age 18 or older, and treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in

510(k) clearances by this applicant