Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Basic Information
- Device Name
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Trade Name
- Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters
- PMA Number
- P100010
- Supplement Number
- S098
- Device Class
- FDA Class 3
- Product Code
- OAE
- Generic Name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 23, 2020
- Date Received
- October 25, 2019
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 20M-1613
Advisory Committee Statement
Approval for the Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheter is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal and persistent atrial fibrillation (episode duration less than 6 months). The Freezor MAX Cardiac Cryoablation Catheter is used as an adjunctive device in the endocardial treatment of paroxysmal and persistent atrial fibrillation (episode duration less than 6 months) in conjunction with the Arctic Front Cryocatheter for the following uses:1) Gap cryoablation to complete electrical isolation of the pulmonary veins;2 Cryoablation of focal trigger sites; and3) Creation of ablation line between the inferior vena cava and the tricuspid valve.
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 |
|---|---|---|---|
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | FDA class 3 | Unknown |