Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters

FDA premarket approval P150005/S035 · decided 2018-08-01

Approval details

PMA number

P150005

Supplement

S035

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters

Generic name

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

Applicant

Boston Scientific Corp

Date received

2018-02-02

Decision date

2018-08-01

Days to decision

180 days

Decision code

APPR

Product code

OAD

Advisory committee

Cardiovascular

Expedited review

No

Location

St Paul, MN

Statement

Approval for expanded indications for use to include the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The devices, as modified, will be marketed under the trade name IntellaTip MiFi Open-Irrigated Ablation Catheter and IntellaNav MiFi Open-Irrigated Ablation Catheter when used with a compatible Radiofrequency Controller and Irrigation Pump, are indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, radiofrequency ablation o

510(k) clearances by this applicant