PMA supplement
P020045 S086: Freezor Cardiac CryoAblation Catheter, Freezor Xtra Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation
FDA PMA supplement · Real-Time Process · Medtronic Cryocath, LP
Key facts
| Original PMA | P020045 |
|---|---|
| Supplement number | S086 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Freezor Cardiac CryoAblation Catheter, Freezor Xtra Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Medtronic Cryocath, LP |
| Product code | LPB |
| Received date | Feb 7, 2018 |
| Decision date | Apr 17, 2018 |
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: