PMA
P020025: EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM
FDA PMA · Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter · Boston Scientific
Key facts
| PMA number | P020025 |
|---|---|
| Trade name | EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
| Applicant | Boston Scientific |
| Owner/operator | Boston Scientific Corporation |
| Product code | OAD |
| Approval date | Aug 25, 2003 |
| Docket number | 03M-0427 |
| Notice date | Sep 17, 2003 |
| Establishment registration | 3005099803 |
| FEI number | 3005099803 |
At a glance
- 100–999 Supplements
- Oct 17, 2025 Latest supplement decision
- No Withdrawn
- Yes 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: