PMA
P040014: IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR
FDA PMA · Cardiac ablation percutaneous catheter · Irvine Biomedical, Inc.
Key facts
| PMA number | P040014 |
|---|---|
| Trade name | IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Irvine Biomedical, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LPB |
| Approval date | Jan 14, 2005 |
| Docket number | 05M-0088 |
| Notice date | Mar 9, 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- No Withdrawn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: