PMA supplement
P020045 S073: FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE
FDA PMA supplement · Panel Track · Medtronic Cryocath, LP
Key facts
| Original PMA | P020045 |
|---|---|
| Supplement number | S073 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Medtronic Cryocath, LP |
| Product code | LPB |
| Received date | Jan 28, 2016 |
| Decision date | Aug 31, 2016 |
| Docket number | 16M-2649 |
| Notice date | Sep 9, 2016 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: