PMA supplement
P030031 S120: CELSIUS THERMOCOOL, THERMOCOOL SF, THERMOCOOL SMARTTOUCH SF, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, and THERMOCOOL SM
FDA PMA supplement · Real-Time Process · Biosense Webster, Inc.
Key facts
| Original PMA | P030031 |
|---|---|
| Supplement number | S120 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | CELSIUS THERMOCOOL, THERMOCOOL SF, THERMOCOOL SMARTTOUCH SF, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, and THERMOCOOL SM |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
| Applicant | Biosense Webster, Inc. |
| Product code | OAD |
| Received date | May 17, 2021 |
| Decision date | Sep 22, 2021 |
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: