PMA
P150005: BLAZER OPEN-IRRIGATED ABLATION CATHETER
FDA PMA · Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter · Boston Scientific Corp
Key facts
| PMA number | P150005 |
|---|---|
| Trade name | BLAZER OPEN-IRRIGATED ABLATION CATHETER |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | OAD |
| Approval date | Feb 24, 2016 |
| Docket number | 16M-0807 |
| Notice date | Mar 7, 2016 |
| Establishment registration | 3004859241 |
| FEI number | 3004859241 |
At a glance
- 10–99 Supplements
- Dec 5, 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- No Withdrawn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: