Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Basic Information
- Device Name
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Trade Name
- Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters
- PMA Number
- P150005
- Supplement Number
- S035
- Device Class
- FDA Class 3
- Product Code
- OAD
- Generic Name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 1, 2018
- Date Received
- February 2, 2018
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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 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 patients age 18 years or older, when used with a compatible mapping system.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | FDA class 3 | Unknown |