PMA
P020045: 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM
FDA PMA · Cardiac ablation percutaneous catheter · Medtronic Cryocath, LP
Key facts
| PMA number | P020045 |
|---|---|
| Trade name | 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Medtronic Cryocath, LP |
| Owner/operator | Medtronic, Inc. |
| Product code | LPB |
| Approval date | Apr 17, 2003 |
| Docket number | 05M-0475 |
| Notice date | Nov 28, 2005 |
| Establishment registration | 3002648230 |
| FEI number | 3002648230 |
At a glance
- 100–999 Supplements
- Apr 23, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: