PMA supplement
P100010 S098: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters
FDA PMA supplement · Panel Track · Medtronic Cryocath, LP
Key facts
| Original PMA | P100010 |
|---|---|
| Supplement number | S098 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| Applicant | Medtronic Cryocath, LP |
| Product code | OAE |
| Received date | Oct 25, 2019 |
| Decision date | Jun 23, 2020 |
| Docket number | 20M-1613 |
| Notice date | Jul 31, 2020 |
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: