PMA supplement
P130026 S049: TACTICATH QUARTZ SET
FDA PMA supplement · Special (Immediate Track) · St Jude Medical
Key facts
| Original PMA | P130026 |
|---|---|
| Supplement number | S049 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | TACTICATH QUARTZ SET |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| Applicant | St Jude Medical |
| Product code | OAE |
| Received date | Jun 27, 2019 |
| Decision date | Jul 24, 2019 |
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: