PMA supplement
P020045 S113: Freezor 207Fl,207F3,207F5, Freezor Xtra 217Fl,217F3,217F5
FDA PMA supplement · Real-Time Process · Medtronic Cryocath, LP
Key facts
| Original PMA | P020045 |
|---|---|
| Supplement number | S113 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Freezor 207Fl,207F3,207F5, Freezor Xtra 217Fl,217F3,217F5 |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Medtronic Cryocath, LP |
| Product code | LPB |
| Received date | Jan 28, 2026 |
| Decision date | Apr 23, 2026 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: