← Product Code LPB · P920047

# EPT-1000 CARDIAC ABLATION SYSTEM (P920047)

_Boston Scientific Corp · LPB · Oct 28, 1994 · Cardiovascular · APPR_

**Canonical URL:** https://fda.innolitics.com/device/P920047

## Device Facts

- **Applicant:** Boston Scientific Corp
- **Product Code:** LPB
- **Decision Date:** Oct 28, 1994
- **Decision:** APPR
- **Device Class:** Class 3
- **Review Panel:** Cardiovascular

## Regulatory 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].

---

**Source:** [https://fda.innolitics.com/device/P920047](https://fda.innolitics.com/device/P920047)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com