PMA
P100010: ARCTIC FRONT CRYOCATHETER SYSTEM
FDA PMA · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation · Medtronic Cryocath, LP
Key facts
| PMA number | P100010 |
|---|---|
| Trade name | ARCTIC FRONT CRYOCATHETER SYSTEM |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| Applicant | Medtronic Cryocath, LP |
| Owner/operator | Medtronic, Inc. |
| Product code | OAE |
| Approval date | Dec 17, 2010 |
| Docket number | 11M-0041 |
| Notice date | Feb 1, 2011 |
| Establishment registration | 3002648230 |
| FEI number | 3002648230 |
At a glance
- 100–999 Supplements
- Sep 25, 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- No Withdrawn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: