PMA
P050029: HELIOS II ABLATION CATHETER
FDA PMA · Cardiac ablation percutaneous catheter · Stereotaxis, Inc.
Key facts
| PMA number | P050029 |
|---|---|
| Trade name | HELIOS II ABLATION CATHETER |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Stereotaxis, Inc. |
| Owner/operator | Stereotaxis |
| Product code | LPB |
| Approval date | Oct 10, 2008 |
| Docket number | 08M-0601 |
| Notice date | Dec 1, 2008 |
| Establishment registration | 3003084417 |
| FEI number | 3003084417 |
At a glance
- None Supplements
- Oct 10, 2008 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: