EPT-1000 CARDIAC ABLATION SYSTEM
Device Facts
| Record ID | P920047 |
|---|---|
| Device Name | EPT-1000 CARDIAC ABLATION SYSTEM |
| Applicant | Boston Scientific Corp |
| Product Code | LPB · Cardiovascular |
| Decision Date | Oct 28, 1994 |
| Decision | APPR |
| Device Class | Class 3 |
Regulatory Classification
Identification
This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].