PMA supplement
P040036 S047: THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER
FDA PMA supplement · Special (Immediate Track) · Biosense Webster, Inc.
Key facts
| Original PMA | P040036 |
|---|---|
| Supplement number | S047 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Biosense Webster, Inc. |
| Product code | LPB |
| Received date | Oct 30, 2014 |
| Decision date | Nov 19, 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: