| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| |
| Device | 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.
150 BAYTECH DRIVE
SAN JOSE, CA 95134 |
|---|
| PMA Number | P150005 |
|---|
| Supplement Number | S014 |
|---|
| Date Received | 02/22/2017 |
|---|
| Decision Date | 12/21/2017 |
|---|
| Product Codes |
OAD OAE |
| Docket Number | 17M-6970 |
|---|
| Notice Date | 01/23/2018 |
|---|
| Advisory Committee |
Cardiovascular |
|---|
| Clinical Trials | NCT01687166
|
|---|
| Supplement Type | Panel Track |
|---|
| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order 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 patients age 18 years or older, when used with a compatible mapping system. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
Labeling Part 2 |
|---|
| Post-Approval Study | Show Report Schedule and Study Progress |
|---|
|
|
