PMA supplement
P020045 S061: FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICES, FREEZOR MAX SURGICAL CRYOABLATION DEVICES
FDA PMA supplement · 30-Day Notice · Medtronic Cryocath, LP
Key facts
| Original PMA | P020045 |
|---|---|
| Supplement number | S061 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICES, FREEZOR MAX SURGICAL CRYOABLATION DEVICES |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Medtronic Cryocath, LP |
| Product code | LPB |
| Received date | Aug 29, 2014 |
| Decision date | Sep 25, 2014 |
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: