PMA supplement
P950005 S066: EZ Steer Non- Navigational 8mm (DS); EZ Steer DS; EZ Steer Non-Navigational 4mm (TC) & (THR); Celsius 4mm Bi-Dir T;
FDA PMA supplement · 30-Day Notice · Biosense Webster, Inc.
Key facts
| Original PMA | P950005 |
|---|---|
| Supplement number | S066 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | EZ Steer Non- Navigational 8mm (DS) ; EZ Steer DS ; EZ Steer Non-Navigational 4mm (TC) & (THR) ; Celsius 4mm Bi-Dir T ; |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Biosense Webster, Inc. |
| Product code | LPB |
| Received date | Jun 30, 2017 |
| Decision date | Jul 27, 2017 |
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: