| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
| |
| Device | POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories |
|---|
| Generic Name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
|---|
| Applicant | Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul, MN 55112-5798 |
|---|
| PMA Number | P220032 |
|---|
| Date Received | 12/20/2022 |
|---|
| Decision Date | 08/08/2023 |
|---|
| Product Code |
OAE |
| Docket Number | 23M-3943 |
|---|
| Notice Date | 09/15/2023 |
|---|
| Advisory Committee |
Cardiovascular |
|---|
| Clinical Trials | NCT04133168
|
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order Statement
Approval for the Boston Scientific Cardiac Cryoablation System using the POLARx Cryoablation Balloon Catheters. The device is indicated for the treatment of patients with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation (PAF). In addition it is intended for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation. The SMARTFREEZE Cryo-Console is intended to be used with POLARx cryoablation balloon catheters only. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
|
|---|
| Post-Approval Study | Show Report Schedule and Study Progress |
|---|
| Supplements: |
S001 S002 S003 |
|
|
