PMA supplement
P030031 S126: THERMOCOOL SMARTTOUCH® Catheter
FDA PMA supplement · Normal 180 Day Track · Biosense Webster, Inc.
Key facts
| Original PMA | P030031 |
|---|---|
| Supplement number | S126 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | THERMOCOOL SMARTTOUCH® Catheter |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| Applicant | Biosense Webster, Inc. |
| Product code | OAE |
| Received date | Dec 22, 2021 |
| Decision date | Jul 18, 2023 |
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: