PMA
P060019: IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF
FDA PMA · Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter · Irvine Biomedical, Inc.
Key facts
| PMA number | P060019 |
|---|---|
| Trade name | IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
| Applicant | Irvine Biomedical, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | OAD |
| Approval date | Mar 16, 2007 |
| Docket number | 07M-0108 |
| Notice date | Mar 26, 2007 |
| Establishment registration | 2030404 |
| FEI number | 1000519796 |
At a glance
- 10–99 Supplements
- Aug 7, 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- No Withdrawn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: