PMA
P040042: THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER
FDA PMA · Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter · Irvine Biomedical,Inc.(Ibi)
Key facts
| PMA number | P040042 |
|---|---|
| Trade name | THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
| Applicant | Irvine Biomedical,Inc.(Ibi) |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | OAD |
| Approval date | Nov 18, 2005 |
| Docket number | 05M-0476 |
| Notice date | Nov 28, 2005 |
| Establishment registration | 2030404 |
| FEI number | 1000519796 |
At a glance
- 10–99 Supplements
- Sep 3, 2026 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- No Withdrawn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: