PMA
P920047: EPT-1000 CARDIAC ABLATION SYSTEM
FDA PMA · Cardiac ablation percutaneous catheter · Boston Scientific Corp
Key facts
| PMA number | P920047 |
|---|---|
| Trade name | EPT-1000 CARDIAC ABLATION SYSTEM |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | LPB |
| Approval date | Oct 28, 1994 |
| Docket number | 95M-0121 |
| Notice date | Jun 7, 1995 |
| Establishment registration | 3005099803 |
| FEI number | 3005099803 |
At a glance
- 100–999 Supplements
- Oct 17, 2025 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: