PMA
P930029: ATAKR(TM) RFCA SYSTEM
FDA PMA · Cardiac ablation percutaneous catheter · Medtronic, Inc.
Key facts
| PMA number | P930029 |
|---|---|
| Trade name | ATAKR(TM) RFCA SYSTEM |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | LPB |
| Approval date | Feb 9, 1995 |
| Docket number | 95M-0057 |
| Notice date | Apr 28, 1995 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 10–99 Supplements
- Jul 1, 2024 Latest supplement decision
- No Withdrawn
- No 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: